(b)(4).The lot # 3000300863 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.
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Trackwise#: (b)(4).Updated sections: b4, d10, g4, g7, h2, h6, h10, h11.Corrected sections: h6--type of investigation code "4114" corrected to code "10" h6--investigation findings corrected from "3221" to "13" h3-- device evaluated by mfg corrected from "no" to "yes" the device was returned to the factory for evaluation on 09/27/2023.An investigation was conducted on 09/27/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.The bisectors, blade, and c-ring were observed to be intact with no visual defects.The blunt tip of the cannula was observed to be damaged and separated from the cannula.The blue toggle was able to be manipulated to retract and extend the cutter blade.The device was evaluated for electrical function.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use (cv000001599).The device passed the pre-cautery test with a reference generator (recommended setting at 18) and reference bipolar cord.An activation test was performed and the device activated repeatedly with no failure observed.The bipolar cord connection was manipulated during activation.The device remained active and no sparks was observed.The device produced steam and the saline was observed to ¿boil¿ on the test gauze each time and no sparks were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to deliver energy" was not confirmed, however the analyzed failure "break; cannula tip" was confirmed.The lot # 3000300863 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.
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