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

Model Number	7205396S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the footswitch was sticking, causing that the shaver blade was running continuously.No patient injuries were reported.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of stuck reverse (left) pedal was confirmed.Footswitch failed functional testing using a known good control unit and mdu.The actuator for the reverse pedal is stuck from corrosion buildup and sticks when depressed.The complaint was confirmed and the root cause was determined to be a corroded reverse 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.

• 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: 7530013
• Report Number: 1643264-2018-00390
• Device Sequence Number: 152222
• Product Code: HRX
• UDI-Device Identifier: 03596010251978
• UDI-Public: (01)03596010251978
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/27/2018

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: 7205396S
• Device Catalogue Number: 7205396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1