Codman disposable perforator was returned for evaluation.Device history record (dhr)- product 261221 with lot 5804671 was reviewed and there is an indication that the production process may have contributed to this complaint.All test results passed procedural specifications, however the 19 units scrapped at the welding step during production indicates that the manufacturing process could have contributed to the complaint condition.Failure analysis- the perforator unit was inspected using the unaided eye: unit was lightly soiled, and received disassembled, there was a shallow weld on the blue sleeve.Ifu testing procedure was performed with no observed anomalies once reassembled with the original parts the unit was returned with.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to not perform as intended with the original parts it was manufactured with, the unit plunged during testing and disassembled.The device was reassembled with a new sleeve, and then performed as intended.Root cause - the complaint was confirmed in the complaint investigation.The device did not function as was intended with the original parts it was manufactured with, and performed as intended once reassembled with new parts.The dhr review also concluded that there were 19 units scrapped in production during the welding step, and due to this, it is possible that the manufacturing process could have contributed to the complaint condition.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.
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