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

Catalog Number	7209692
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cord of the footswitch was burned and fell off.This was noticed before the procedure; therefore, no patient was 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 no relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and revealed the cord is not burnt but rather scuffed up and is still attached.Complaint of overheating could not be reproduced.The foot-switch passed functional testing.All functions perform as expected.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.

• 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 6512
• MDR Report Key: 9216688
• Report Number: 1643264-2019-00719
• Device Sequence Number: 11299073
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2019

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 Catalogue Number: 7209692
• Device Lot Number: 18172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 12/10/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/10/2019; 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1