Model Number PL572T |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2021 |
Event Type
Injury
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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, during the surgery, the magazine was deformed.The tip of the magazine was deformed (bent) and fell into the patient's body.The product has been recovered and there is no health hazard to the patient.The plate has come into contact with an obstacle or is damaged.The complaint device has not been received by 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 adverse event is filed under aag reference (b)(4).
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Manufacturer Narrative
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Updated: b5 intervention required; d9 no product return; h6 codes.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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Event Description
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Clarification: an additional medical intervention was required.
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Search Alerts/Recalls
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