Investigation: initiated manufacturer's investigation, no sample returned , review dhr , analysis and findings.Distribution history.The complaint product was manufactured at csi on 06/24/21 under work order (b)(4) review of fg inventory reveal that lot 307280 was depleted.Manuf.Record review dhr - 307280 was reviewed and was found to have non-conformity unrelated to the complaint condition.The work order was reworked and subsequently resubmitted for qc inspection and passed.Incoming inspection review incoming inspection record review not applicable to this product.Service hist.Record service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.This complaint condition is an isolated event.Product receipt the complaint product has not been returned to coopersurgical.There is currently no rma for the product.Visual eval.Evaluation of the complaint unit could not be completed as the complaint unit has not been returned.If the unit should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.However, photos where attached and provided with the complaints.Complaint condition will be considered as verified based on the photo.Functional evaluation evaluation of the complaint unit could not be completed as the complaint unit has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause no definitive root cause for this issue could be reliably determined at this time.The cuff part number 38265 did not undergo any design change.The cuff is made from hs-714, a class vi bio compatibility for plastics, passing iso10993-5 cytotoxicity test.Additionally, a review of the validated assembly process at the manufacturing facility did not reveal any potential gaps whereby the heatshrink cuff could not have been shrunk in place.During the review of the provided information, it is noted in the complaint details that the uterine balloon was inflated with 20cc of saline.The ifu (38501-ifu-b) states that the uterine tip balloon to be filled with up to 10cc of air.It is unknown what effects 20cc of saline in the balloon could cause.The complaint details also states that the advincula delineator was sutured in place.The ifu does not indicate nor give instructions for suturing the device in place.It is unknown if the suturing of the product in place places or adds additional forces to the device that is not within the intended use of the product, however, it may have lead to the failure of the device.Corrective actions: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not determined to be a manufacturing issue.As a precaution, a quality alert (qa-00393) was created to alert the manufacturing floor of the complaint condition.The product met the required release specifications per dhr review.No re-training required.*was the complaint confirmed? yes.
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