Evaluation summary: one 23ga probe was returned for the probe becoming occluded and stopped working.The probe initially worked fine.For this complaint file, the final customer lot was identified.For this final lot, five component probe lots were used to make up the final lot.A device history record review for each of the five lots was conducted.According to the device history record review, one lot was reprocessed for an anomaly that did not contribute to the customer complaint.No anomaly was found during the device history record reviews for the other four lots.The product was released based on the product¿s acceptance criteria.Aspiration testing was performed and deemed conforming.Actuation and cut testing was performed and deemed nonconforming.The cutter was never observed in the port during testing.The probe was disassembled and the components inspected.There was approximately 15 minutes of usage wear on the inner cutter when compared to the cutter wear visual standards.There was no resistance felt when removing the needle from the inner cutter.There were wear marks at the bend area.The actuation test was repeated after the disassembly of the outer needle and the testing was then deemed conforming.The inner cutter diameter was measured and deemed conforming to insure the correct 23ga cutter needle was used for the probe assembly.The complaint evaluation did confirm the probe stopped working during its use.The evaluation did not confirm the probe was blocked.The probe aspirated to specification.The probe testing indicated both actuation and cut testing were nonconforming.The investigation did indicate the probe initially did actuate and cut for approximately 15 minutes.At some point in its surgical use there appeared to have been some unknown reason that impeded the movement of the inner cutter within the outer tubing.Possible reasons for this interference could be foreign material being wedged between the cutter and needle, the drifting of the cutter bend angle during its use, or the cutter becoming misaligned during its use.The exact reason for this restriction of movement of the cutter cannot be determined from this evaluation, but when the resistance was eliminated by disassembly of the probe outer needle from the cutter, the cutter movement was then good and able to actuate.
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