The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that a piece of the septum, an internal rubber component of the seal, had separated from the seal.Engineering also observed that the shield, an internal plastic component of the seal, was dislodged within the seal.Applied medical has reviewed the details surrounding the event and related product.At this time, applied medical is unable to determine the root cause of the customer¿s experience.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Septum fragmentation is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.However, the event is reportable due to the dislodged shield that was observed during the evaluation of the returned unit.
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Procedure performed: unknown.Event description: this is a complaint from the market.Please refer to the complaint sheet for investigation.Large resistance of the insertion , and detachment of the septum.Report from the sales rep: after four hours, the resistance of insertion the scope had increased and the septum was popped out when removed from seal component.Initial investigation report: the event unit was returned to us and visually inspected.The septum was detached from the seal component.No visual damage was found in the ddb and shield.The unit will be returned to amr for further evaluation.Patient status: no patient injury.
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