MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AEX GENERATOR-REFURB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	40-405-1R
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Codes	Burn(s) (1757); Electric Shock (2554)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) regarding a generator and handpiece.It was reported that while using the generator, a scrub tech stated they received a shock while leaning on a wet towel near the patient while the handpiece and generator were being used.There was no harm to patient.Scrub tech only had a red mark on their skin.Additional information was received from the hcp and it was further stated that after some clarification and information concerning this case with the operating surgeon¿s help, the equipment was working normally.The operating surgeon continued with the case using the same equipment and hand piece without any problems.The operating room had only one model handpiece for the use of this equipment.The handpiece was discarded.There was no spark or arc seen.The rep was uncertain that there was a shock.The same equipment and hand piece was used to complete the procedure.

• Brand Name: AEX GENERATOR-REFURB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 10403740
• Report Number: 1226420-2020-00088
• Device Sequence Number: 19798318
• Product Code: GEI
• UDI-Device Identifier: 00643169859708
• UDI-Public: 00643169859708
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40-405-1R
• Device Catalogue Number: 40-405-1R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other