Kenneth Smalley

In circumstances it is my statutory duty to report to you: (1) During the inquest evidence was heard that The damage to the spleen was unlikely to have been due to the malfunctioning of the operating table During the surgery the operating table moved uncontrollably without operation of the handset until it stopped in the Trendelenburg position; The handset was last serviced by the Eschmann Group on the 140 December 2012 when no defects were identified but after that date the handset had been opened at some point; The handset is not a serviceable item and the handsets are replaced as sealed units only and are not repairable. The opening of the handset can compromise the seal that protects the circuit board and the button contacts from fluid ingress: There was evidence of tarnish on the handset Trendelenburg button electrical contacts within the handset indicating possible moisture ingress at this point; iv) The handset had been left on the of the Operating Theatre and not in the correct position on the side of operating table: The bracket to attach the handset to the side of the operating table was missing at time of inspection after the incident; The handset emergency stop button should stop the movement of the operating table at all times but on this occasion emergency stop button did not cause the operating table to stop: The Eschmann Group confirmed that the emergency stop button is not isolated from the arcuit board within the handset nor within the handset itself to ensure that it operates separately from other functions within the headset; Over the last 5 years the Eschmann Group has recorded 6 other incidents of unrequested powered table movement in relation to operating tables with 4 incidents where no fault was found and the issue could not be replicated: One incident was traced to handset damage and one incident traced to possible fluid ingress into a circuit board. In the case of the incident relating to the deceased no explanation could be given for the malfunction of the operating table other than possible fluid ingress but there was no evidence of_ fluid on the_floor of the Operating_Theatre at the floor the the the the time of surgery and the table had functioned without incident in relation to surgical procedures on previous vii) The Royal Albert Edward Infirmary has similar operating tables with similar handsets in the Hospital but no review has been carried out by the Hospital in relation to those operating tables and handsets, particularly as to whether the handsets have been opened with damage to the seals: viii) Whilst pre-operation checks of equipment are conducted by Surgical and Theatre teams at the Hospital prior to each surgical procedure, the checks do not appear to cover the position of the handsets or whether the handsets had previously been opened or subjected to tamper: Training and Auditing are required in relation to such matters; ix) The incident was reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) who conducted an investigation but the conclusions of the Investigation and guidance has not been shared with the Wrightington, Wigan & Leigh NHS Foundation Trust; There appeared to be very little, if any, contact between the MHRA, the Eschmann Group and the Wrightington; Wigan & Leigh NHS Foundation Trust to enable the sharing of information for lessons to be learned and actions to be taken; (2) Ihave concerns with regard to the Wrightington, Wigan & Leigh NHS Foundation Trust in relation to The function of operating tables and handsets particularly the review of all operating tables ad handsets used at the Hospital follwing the incident on the March 2013. ii) Pre-operation checks of equipment particularly the function of handsets attached to operating tables with particular attention to the general condition of the handsets, the seals, and the position of the handsets at the side of the operating table to avoid the handsets placed on the floor of the Operating Theatre to reduce the risk of fluid ingress: iii) The procedures relating to inspection of operating tables and handsets used at the Hospital particularly to identify any damage to the handsets to ensure the immediate replacements of any damaged handsets_ iv) The training of staff in relation to pre-operative checks of equipment in the operating theatres at the Hospital with emphasis on operating tables and handsets including the correct positioning of the handsets with effective auditing of such inspections: (3) I have concerns with regard to the Eschmann Group in relation to review Of operation of handsets attached to operating tables in view of the number of unexplained and uncontrolled movements of operating tables with particular reference to the isolation of the emergency stop button on the handsets to ensure that the emergency stop button operates in all circumstances whether there is damage to other parts of the handset: (4) I have concerns with regard to the Medicines and Healthcare Products Regulatory Agency in relation to contact with all interested Agencies following an investigation to ensure the sharing of information with all interested_Agencies_particularly_to_enable_lessons_to_be_learned_ and days: any 27t being the corrective action to be taken as soon as possible: ACTION SHOULD BE TAKEN In opinion urgent action should be taken to prevent future deaths and I believe you and/or your organisation have power to take such action: YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report; namely by 13th February 2014. 1, the coroner, may extend the period;, Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. COPIES and PUBLICATION I have sent a copY of my report to the Chief Coroner and to the following Interested Persons The son of Kenneth Smalley. Iam also under a duty to send the Chief Coroner a COpY of your response: The Chief Coroner may publish either or both in a complete or redacted or summary form: He may send a cOpY of this report to any person who he believes may find it useful or of interest: You may make representations to me; the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. Dated Signed 19th December 2013 Alan P Walsh my the