The complaint device was returned to stryker sustainability solutions (sss) for an evaluation.Visual examination of the returned device revealed evidence of clinical use including biological material on the distal tip as well as an indentation in the teflon pad.Visual inspection confirmed the reported issue as the blade was broken off.The results of the investigation performed indicated that the blade of returned device broke as a result of the blade contacting a hard object, possibly a staple or surgical clip, during clinical use (i.E.End user technique contrary to the ifu)."avoid contact with any and all metal or plastic instruments or objects during instrument activation.Contact with staples, clips, or other instruments during instrument activation may result in premature blade failure, resulting in generator solid tone or instrument error.¿ a review of the lot control sheet for the reported device indicated the device passed all inspections prior to release from sss.
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