MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH,EP-1,PEDAL STYLE,; ARTHROSCOPE

Model Number	7205396
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pedals periodically are sticking causing the device to continually run.No case involved.No user injury reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
H3,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.A visual inspection was performed on the exterior of product and no physical damage was observed.Complaint of sticking right pedal was confirmed.Footswitch failed functional testing using a known good control unit and mdu.The actuator for the right pedal is sticking from corrosion buildup and sticks when depressed.The complaint was confirmed and the root cause has been determined to be corrosion of the right pedal actuator.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.A complaint history review found related failures.No containment or corrective actions are recommended at this time.

• Brand Name: FOOTSWITCH,EP-1,PEDAL STYLE,
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8345764
• Report Number: 1643264-2019-00111
• Device Sequence Number: 2287505
• Product Code: HRX
• UDI-Device Identifier: 03596010251961
• UDI-Public: 03596010251961
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2020

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: 7205396
• Device Catalogue Number: 7205396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 03/06/2020
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/19/2019; 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1