MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH VULCAN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	7209692
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the footswitch was not activating.It is unknown whether the event happened during surgery and if there was a patient involvement.The unknown procedure was completed using a back up device and no delays were reported.
Additional Manufacturer Narrative
H10 h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection observed the cable connector was opened to check the wiring and the ground wire (black) was loose inside the cable connector.Functional evaluation revealed both pedals did not function.The complaint was confirmed.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include an excessive tensile stress applied to the cable could have partially broken one or more signal wires prematurely.

• Brand Name: FOOTSWITCH VULCAN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10340702
• Report Number: 1643264-2020-00705
• Device Sequence Number: 3065034
• Product Code: GEI
• UDI-Device Identifier: 03596010470546
• UDI-Public: 03596010470546
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K050898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7209692
• Device Catalogue Number: 7209692
• Device Lot Number: 343994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1