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 07/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that pl572t was used during laparoscopic procedure performed on (b)(6) 2021.According to the complaint description, during the second shot, the clip was clogged, the clip magazine body fell off from pl604r, and the magazine fell into the patient's abdominal cavity.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
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Manufacturer Narrative
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Correction / additional information: b5: product name.H6: codes.Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital-camera and 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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Event Description
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Correction: added the "product name".It was reported that there was an issue with pl572t - ligature clip 12 mag.= 144 pcs.
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Search Alerts/Recalls
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