The product was not returned for evaluation.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 pod12 as the pod12 was caught on the patient drape upon removal from the packaging.The damage to the pod12 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new pod12.
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