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 disposed of the device.
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During preparation for a coil embolization procedure, the hospital technician found that the back of the pusher assembly of the pod6 (pod6) was bent upon removal from the packaging.The damage to the pod6 was found prior to use.Therefore, the pod6 was not used in the procedure.The procedure was completed using new pod coils.
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