Please note that the following device code also applies to this complaint: (b)(4).The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital discarded the device.
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During preparation for a coil embolization procedure, the hospital technician accidentally bent the pusher wire of a pod5 while removing it from its packaging hoop.The damage to the pod5 occurred prior to use, and therefore it was not used in the procedure.The procedure was completed using a new pod5.
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