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 inadvertently bent the pusher assembly of the pod packing coil (podj) upon removal from the packaging.The damage to the podj was found prior to use.Therefore, the podj was not used in the procedure.The procedure was completed using new ruby coils.
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