The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant's experience of seal component separation.The duckbill, a rubber component of the seal, was dislodged from the seal.Engineering observed that the septum, another rubber component of the seal, was torn and fragmented.Based on the condition of the returned unit and the description of the event, it is likely that damaged septum was caused by non-axial insertion or removal of asymmetrical instruments (clip applier) through the trocar.Applied medical's instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical has reviewed the details surrounding the event and related product and is unable to determine the exact root cause of the dislodged duckbill.It is possible that the duckbill dislodged due to non-axial insertion of asymmetrical instruments (clip applier).The probability and criticality of harm resulting from this failure mode has been evaluated and were found to be at an acceptable level.A torn and fragmented septum is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.The event is being reported due to the dislodged duckbill that was observed during the evaluation of the returned unit.
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Procedure performed: event description: seal component fragmentation.Report from the sales rep: when inserted the [non-applied] clip applier, the customer felt the insertion resistance.And in the time of intraperitoneal irrigation, the valve damage was found.All damaged parts were recovered.Initial investigation report by distributor: the event unit was returned to [distributor] and visually inspected.The ddb was already disassembled on arrival.The septum was fragmented and torn (pic.1).The fragment was not returned.No visual damage was found in the ddb and shield.The unit will be returned to amr for further evaluation.Admin# c19210936.The component list was provided and the seal, ddb and obturator are available for return.Intervention: all damaged parts were recovered.Patient status: no patient injury.
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