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

Model Number	7209692
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the vulcan footswitch was not working.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 a rusted base and the cable connector lockring is missing.Functional evaluation revealed the ablate pedal does not function when pressed, the coag pedal works as intended.The complaint was confirmed and the root cause is associated with electrical component failure.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 causing non-functionally of the pedal.There may have been a loose cable connection between the returned device and the used controller, which could cause non-functionality of the device.No containment or corrective actions are recommended at this time.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

• 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: 11486117
• Report Number: 1643264-2021-01014
• Device Sequence Number: 3430373
• Product Code: GEI
• UDI-Device Identifier: 03596010470546
• UDI-Public: 03596010470546
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 621274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1