Trackwise # (b)(4).The device was returned to the factory for evaluation on 10/17/2023.An investigation was conducted on 10/25/2023.A visual inspection was conducted.Both the harvesting device as well as the cannula was returned for evaluation.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact cannula.There were no visual defects observed on the intact jaws and heater wire of the harvesting device.The shaft of the harvesting device was observed to be bent in the center of the shaft.The black shaft closest to the base of the jaws was observed to be peeled back from the base of the jaws, exposing the inner portion of the base of the jaws.No other visual defects were observed.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter and reference power supply at level 3.0.The device did turn on and an audible sound was heard when activating the toggle.The device passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations.The device was tested for the safety shut down system as the device would turn on, and produced visible steam.An activation and transection capability test was performed over two (2) repetitions using "max life test method stm2048073 rev aa.The device successfully transected tissue two (2) times.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).A temperature and resistance test was not conducted due to the condition of the peeled shaft at base of jaws as well as the bent shaft.Based on the returned condition of the device as well as the evaluation results, the reported failure "intermittent continuity" was not confirmed, however the analyzed failures "peeled; delaminated; shaft" as well as "material twisted/ bent shaft" were observed.The lot # 3000327881 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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