Seven opened probes were received with tip protectors, in bubble bags along with a usb, for the report of ceased to actuate and cutting failure occurred.Sample #1 was visually inspected and found conforming.The probe was then functionally tested for actuation and cut.The sample was found to be conforming for cut and was non-conforming for actuation.Sample #1 was then disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at the cutting edge and several other locations along the inner cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate.Sample #2 was visually inspected and found non-conforming with orange/brown foreign material on the port face and on the back of the probe needle.The probe was then functionally tested for actuation and cut and was found to be non-conforming for both functional tests.Sample #2 was then disassembled and the components inspected.Nominal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at the cutting edge and several other locations along the inner cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate.Sample #3 was visually inspected and found conforming.The probe was then functionally tested for actuation and cut.The sample was found to be conforming for actuation and was non-conforming for cut.Sample #3 was then disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at the cutting edge and several other locations along the inner cutter.Sample #4 was visually inspected and found to be conforming.The probe was then functionally tested for actuation and cut and was found conforming for both functional tests.Sample #5 was visually inspected and found to be conforming.The probe was then functionally tested for actuation and cut and was found conforming for both functional tests.Sample #6 was visually inspected and found to be non-conforming with orange/brown foreign material on the port face.The probe was then functionally tested for actuation and cut and was found conforming for both functional tests.Sample #7 was visually inspected and found non-conforming with orange/brown foreign material on the port face.The probe was then functionally tested for actuation and cut.The sample was found to be conforming for cut and was non-conforming for actuation.Sample #7 was then disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at several locations along the inner cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirms that three of the returned probes had actuation failures (samples 1, 2 & 7) and two of the returned probes had cut failures (samples 2 & 3).The cause for the cut failures in samples 2 & 3 is the observed gouges on the cutting edge of the inner cutter of the probe.A damaged cutting edge can decrease the quality of the cut performed by the probe.How and when the cutting edge of the inner cutter of the probe became damaged cannot be determined form this evaluation.The exact cause of the actuation failures in samples 1, 2 & 7 cannot be determined from the evaluation performed.No specific action with regard to this complaint was taken by the manufacturing site because the exact root cause of the actuation and cut failures cannot be determined.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will be continued to be reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required the manufacturer internal reference number is: (b)(4).
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