Trackwise#: (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h10.The device was returned to the factory for evaluation on 03/21/2024.An investigation was conducted on 03/26/2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed on the returned blade.There were no visual defects observed.A mechanical evaluation was conducted.The returned blade was attached to a reference retractor with no visual or physical difficulties.Based on the returned condition of the device as well as the evaluation results, the reported failure "mechanical problem" was not confirmed.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.A lot history record review was completed for lot 3000365546, the only lot shipped to the account in the year prior to the event date.There were no ncmrs, rework, or deviations documented for the last lot shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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