System consists of the following devices: inner sheaths, working element, bipolar cable, electrode, generator, powercable, footswitch, endoscope, outer sheath, rotatable connector.The inner sheath, working element and bipolar cable were returned for investigation.No issues were found with the three device returned for investigation., therefore the most likely suspect device was the electrode.The suspect device was discarded by user facility and not available for investigation.Two possibles which may have lead to doctor getting shocked: electrode may have been damaged, inadvertent activation of footswitch while holding instrument system.No similar issues on this device on the last three years.Labeling was reviewed and found to be adequate.Ie intended use, indications, combinations, reprocessing "disposable" devices, cautions and warnings of the dangers of electric shock.Rwmic considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.Discarded by user facility.
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Facility called richard wolf medical instruments corporation (rwmic) and report that during a case the doctor picked up instrument system and was shocked.No injury to patient or any other staff reported.System consists of the following devices: inner sheaths, working element, bipolar cable, electrode, generator, powercable, footswitch, endoscope, outer sheath, rotatable connector.Only inner sheaths, working element & bipolar cable were submitted for investigation.
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