Model Number PL430R |
Device Problems
Break (1069); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).When additional information is received a follow up report will be submitted.
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Event Description
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It was reported "that the tip broke off during a laparoscopic hysterectomy procedure.The myoma screw was placed into the uterine wall and broke during surgery.The tip was retrieved and removed from the patient." no x-rays were needed to retrieve the tip.Additional patient outcome information has been requested and when the information become available it will be forwarded over.
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Manufacturer Narrative
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No products at hand.There a failure description is not possible.No product at hand.There an investigation is not possible.A review of the device quality and manufacturing history records was not possible because the lot number is unknown.Based on the information available it is not possible to determine a possible root causes for the failure.It could be possible that the failure is usage related.Due to the circumstances that we did not receive the device for the investigation is it not possible to determine a conclusion and root cause.In light of past experience and without any further information we assume that the complained instrument was overload either during the application itself or during reprocessing or by being dropped on a hard surface.A capa is not necessary.
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Search Alerts/Recalls
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