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Lumenis received from (b)(6), adverse incident report concerning the versacut tissue morcellator.The hand piece was connected to the wrong side of the pump raising a potential user interface problem.As a precaution the user has added their own label, in addition to existing devices labels instructing proper orientation, to help ensure correct orientation of connection.There was no injury to patient or user and the event did not involve any device malfunction.Lumenis contacted the user facility directly in order to obtain additional information regarding the reported event.No additional information had been provided.A review of subject device risk files identified the follow risk: improper use - inverted aspiration direction - tube is assembled in the wrong direction (0635-682-01_j versacut morcellator system risk-hazard analysis, risk #: 3.2.1).Mitigation method: illustration is applied on pump (front and up view) to guide the physician.Operator manual instructs user about the proper use of the system and components.Tissue collection container's one-way valve prevents inverted aspiration direction.Operator manual shall advice on recommended steps before morcellation.Thus, the user shall be recommended to test flow direction with sterile saline water - before device is inserted to patient and morcellation starts.The risks have been quantified and found to be remote, and the risks have been characterized and documented as acceptable within full risk assessment.A review of subject device labeling, (0631-060-01_k versacut operator manual) revealed: the user manual instructs the user to "test the system before patient operation" and to "ensure that the liquid is flowing in the direction of the arrow on the label adhered to the pump head, and on top of the system's casing".In addition the user manual also requires that "physicians and support staff must be fully familiar with the operation and biological effects of the instrument and the safety precautions associated with its use." lumenis believes this is basically a concern raised by a user, where they initially put the tubing into the versacut machine in the wrong direction.They probably discovered this by following the instructions for use that clearly instructs users to test the flow first to make sure it is in the right direction.There are two warnings with regard to this in the um and two labels on the machine itself showing which way the tubing should be connected.This complaint is clearly not reportable in the usa or in eu (under meddev 2.12-1 rev 8).Furthermore, based on the following (b)(6) regulation: 2019 no.Exiting the (b)(6) union - consumer protection.The medical devices (amendment etc.) ((b)(6) exit) regulations 2019.This incident is also not reportable to (b)(6) for some of the same reasons that it isn't reportable in (b)(6) (ie.Because the word "incident" refers to actual malfunctions as described in the definitions on pages 78-79, and there was no malfunction here, and also because this is a foreseeable effect warned about in the user manual, and in this case it was a user error which they caught).To conclude, investigation revealed there was no device malfunction.There are manufacturer labeling on the device and user is instructed to read and follow the um for additional testing detailed in the um prior to using device to prevent such user error that may lead to an incident and/or harm to the patient.Therefore, we conclude that based on the event details provided by the user and conforming to regulations, this event is not reportable in (b)(6), neither in the usa or (b)(6).Lumenis is sending it's response to the (b)(6) report ((b)(4)).Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop ((b)(4)) and per post marketing surveillance procedure ((b)(4)).Update 28-apr-2021 as noted in the manufacturer's narrative, soon after lumenis first received this report in (b)(6) 2021, lumenis sent to the reporting facility clarifications questions.These questions were not answered at the time.Then, on (b)(6) 2021 (3 months later), the facility responded with additional details about the adverse event.However, the version now is different from the earlier version and, some of the details that he provided now, do not conform to one another nor with the initial report that was sent by him to the mhra.According to his new report: patient arrived in theatre for a holep procedure.The scrub nurses and the circulating nurse connected the morcelator tubing and tested it.The circulating nurse remembers checking it the machine with the tubing in place and everything was working appropriately.After 30 seconds to a minute when surgeon started the morcellating process they realised that the prostate chips were going up the giving set as the machine was blowing air into the patient instead of sucking the fluid out of the patient.They changed immediately the tubing into the morcelator machine.After another 10 minutes patient arrested, the procedure was stopped.After connecting the tubing into the morcelator machine the scrub nurse and the circulating nurse checked the position of the tubing by immersing the morcellator hand piece into a receiver filled with fluid.Both of them said that the machine and tubing were working correctly.Physician and theatre staff were familiar with the procedure and the equipment.The scrub nurse was quite new but she was supervised by experienced staff.All theatre staff was complying with the requirement." the initial report did not include any mention of injury to the patient or even a delay in procedure, merely stating a concern for potential user interface following connection of the handpiece to the pump in the wrong direction.More specifically, the initial report indicated "none" for the question "type of injury".The current report implies cardiac arrest of the patient during the procedure.The initial report to the (b)(6) was clear and stated that "the hand piece was connected to the wrong side of the pump".However, the second report is ambiguous and contradicts itself.It says that the nursing staff performed the tests (according to the user maual) prior to the procedure and it worked properly, but then, "after 30 seconds to a minute.Surgeon.Realised.The machine was blowing air into the patient instead of sucking the fluid out of the patient.They changed immediately the tubing into the morcelator machine".If indeed this test was performed correctly prior to the procedure, there is no reason for changing the tubing after 30 seconds to a minute.Per this second report, it is clear there was no malfunction of the device, since the second report reads "both of them (scrub nurse and the circulating nurse) said that the machine and tubing were working correctly".Lumenis requested addition clarifications and information from the foreign user however the following questions remained so far, without answer: why such integral information was missing from the original report.What medical interventions were required? what tests have been carried to identify the pathology/reason of the cardiac arrest? what is the state of the patient now? did they indeed view that the suction was going in the right direction during the test and not just confirming activation of the system? was the test performed immediately prior to the procedure on the patient? were any alterations made on the device assembly after the test and prior to the procedure? according to the original mhra report submitted by the facility and also their clarification mail 3 months later, there was actually no malfunction, it is most likely that a user error, failure to test the system prior to the operation, that led to this event and therefore no need for a corrective action.However, since this event led to an alleged injury and cancellation of the procedure, in an abundance of caution lumenis is reporting this event as lumenis believes that subjecting a patient to another round of anesthesia carries inherent risks.Lumenis is closing this complaint, but will continue to monitor this user failure mode; complaint trending will continue to monitor per global complaint handling sop ((b)(4)) and per post marketing surveillance procedure ((b)(4)).
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