It was reported that there was an issue with pm438r - jaw ins.Bip.Maryland diss.Fen.5/310mm.According to the complaint description, the hinge on the working end was broken during surgery.During the operation, suddenly only one of the jaws at the tip broke.The debris was collected immediately, and there were no abnormalities in the progress of the operation or the patient's condition.There was no described patient harm.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Involved components: pm600201 - metal inner tube 31cm.
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Updated h4: manufacturing date updated h6: codes based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.Investigation results: visual investigation: the instrument provided is in a used condition, one of the jaw parts is broken off, the shaft is slightly bent.Vigilance investigator carried out the pictorial documentation visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload e.G.Leverage or torsion during application or reprocessing.No pores, inclusions or foreign bodies could be found on the point of rupture.To avoid damages to the instrument, ifu must be observed.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso (b)(4) is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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