MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH, EP-1, LOW PROFILE,W/; ARTHROSCOPE

Catalog Number	7205399
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 device was burned.It was found before a procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the returned device noted that there is a small tear in the cord¿s insulation near the strain relief.Complaint of burnt cord could not be confirmed.No evidence of burnt or melted insulation was observed on cord.Footswitch passed all functional tests.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.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: FOOTSWITCH, EP-1, LOW PROFILE,W/
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9205673
• Report Number: 1643264-2019-00713
• Device Sequence Number: 2950317
• Product Code: HRX
• UDI-Device Identifier: 03596010252036
• UDI-Public: 03596010252036
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K892062
• Number of Events Summarized: 1
• Summary Report (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): 11/25/2019

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: 7205399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1