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

Model Number	7209692
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).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 is crushed in one section, separating the cables internally. functional evaluation revealed the unit does not function when activated.The complaint was verified.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include damage sustained to the device, which could have been caused by running over with another portable object/machine, being stepped on or being dropped.
Event or Problem Description
It was reported that footswitch,vulcan did not work.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that the device did not function when activated, which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 11496488
• Report Number: 1643264-2021-01044
• Device Sequence Number: 14831006
• Product Code: GEI
• UDI-Device Identifier: 03596010470546
• UDI-Public: 03596010470546
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K991140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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: 362090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1