The device was not received for evaluation as it remains implanted.Without the benefit of analyzing the device, quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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According to the available information the penile implant was revised due to a malfunction.Additional information indicated that there appeared to be a leak somewhere in the system.When an incision was made and tubing was exposed, the connector was found to have dislodged.When the tubing was connected, the tubing was not inserted entirely which resulted in a missed connection with the pump and reservoir junction.The tubing was re-spliced and new connectors were inserted and snapped together.
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