Investigation x-inspect returned samples *analysis and findings complaint # (b)(4).Distribution history: this complaint unit was manufactured at csi on 4/25/2000 under wo #8408 and shipped 2000.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at this time.However, at the time of manufacture, records from each unit are reviewed to ensure that product meet all specifications.Should the device history record be located, this complaint will be amended accordingly.Incoming inspection review: n/a service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log 95204.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: unit was functioning properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.No root cause is applicable.Corrective actions relevant to the updated diaphragm are as follows; the diaphragm was changed out due to a previous finding where the material degraded to the point where it no longer functioned as intended and prevents activation of a unit.This unit's diaphragm was in working order.However, the corrective action for this issue requires returned units be updated to the new material and applicable on this unit.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.Corrective actions relevant to the updated diaphragm are as follows; coopersurgical service and repair replaced the diaphragm on the unit, tested it and returned it to the customer.Engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.All product in fg and sk, as applicable, were reworked to replace the previous versions of the dfus on all applicable products.The repaired unit will have been repaired with this new silicone material.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
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