Trackwise#: (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h10, h11.Corrected sections: (b)(6).The lot # 3000363092 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.H3 other text : device not returned.
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(b)(4).Corrected sections: h6--component codes corrected from "4756" to "4774" as device was returned.The device was returned to the factory for evaluation on 04/25/2024.An investigation was conducted on 05/01/2024.Signs of clinical use and evidence of blood and charred material were observed.The heater wire and clear silicone insulation of the jaws were observed to be intact with no visual defects.Charred material was observed between the jaws, however there was no foreign material observed between the jaws.The cannula and c-ring were observed to be intact with no visual defects.Based on the investigation results, returned condition of the device, and the no specific failure reported, there were no defects observed with the device.
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