The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Dents and scratches were seen on the insulation.Also the screw that holds the handle in place is missing and was not received with the instrument.In addition it was noticed the pn and lot# etchings are not present.The insulation is a non stryker part.Since this is non monopolar instrument a insul scant test was not performed.However, ifu states "before use, ensure that there are no breaks, chips, cracks, scratches, tears, or missing/loose components on the shaft insulation, handle, or housing.Do not use the instrument if any of these defects are present as this could cause unintended electrosurgical burns and life threatening complications.If damage has occurred, discontinue use and return the instrument for repair or replacement." the probable root causes are normal wear, improper sterilization methods, user misuse, third party repair, and disassembly of the handle at the account.
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