It was reported that in central processing, it was noted that the sealing edge of the working jaw split apart on the harmonic ace curved shears insert accessory.There was no report of fragments falling into the patient.There was no patient harm, adverse outcome or injury reported.
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The instrument was returned and evaluated.Failure analysis investigation found the harmonic ace insert had teflon pad damage.The teflon pad was peeling off, when pushed down, no material appeared to be missing.Failure analysis concluded that the teflon pad damage was likely due to mishandling/misuse.No other damage was found.The endowrist® instruments instructions for use (ifu) specifically states: general precautions and warnings handle instruments with care.Avoid mechanical shock or stress that can cause damage to the instruments.The customer reported complaint does not in itself constitute a mdr reportable event; however; the teflon pad damge if to recur could cause or contribute to an adverse event.
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