(b)(4): one (1) sp90-7836 dtouch2 fenest dissector was returned for evaluation.Evaluation by the lead manufacturing technician and quality engineer did not confirm the reported failure.Visual and functional inspection was performed and resulted in the conclusion that the sample functioned as normal, with both the ratchet and rotation knob activating as intended.The overall sharpness was then examined, in which the sample was declared to have no raised edges and was of the usual beveled edge.According to the records the device has been in the possession of the customer for 5 years without a repair or a complaint from the customer.This edge has also not been an issue over the 5 years this sample has been in existence.Testing was performed on muslin cloth with a pulling force.No tearing or cutting was observed on the cloth.There are many unknowns concerning the reported failure: the amount of procedures the sample has endured, the amount of usage, the amount of uses in which the sample did not cause excess trauma and the amount of wear upon the instrument.In addition, it is unknown of the user technique and the force that was applied to the tissue during the surgery which was performed.This would indicate the amount of trauma in which the cut bowel endured.As this device was found to be within specification, as a recommendation the use of a bowel clamp might be better suitable for usage since it has longer jaws with 2x3 rows of smooth teeth and is available under product numbers sp90-7845 and sp90-7846.A review of the device history record (s) did not reveal non-conformances.The devices passed all acceptance criteria for release.Conclusion(s): other- not confirmed the reported failure could not be duplicated.Bd will continue to trend and monitor this reported issue and for this product family.
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