Model Number PL572T |
Device Problem
Unintended Ejection (1234)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported to aesculap ag that a ligature clip 12 mag.= 144 pcs (part # pl572t) was used during a procedure performed on (b)(6) 2021.According to the complainant, the clip magazine fell off during surgery.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital-camera.Here broken off noses, broken off latches and clip jams were found.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 3(5) x probability of occurrence 3(5)) according to din en iso 14971 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 psc 2021-113 has been initiated.Any action regarding capa will be addressed with this case.
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Search Alerts/Recalls
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