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

Model Number	7205396S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaver pedal would get stuck in the on position and keep running while inside the joint.No patient injury reported.
Additional Manufacturer Narrative
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.Functional evaluation revealed the footswitch reverse pedal is stuck in the depressed position due to corrosion buildup of the actuator.The complaint was confirmed and the root cause was determined to be a corroded actuator.Certain cleaning or disinfecting chemicals coming into contact with the actuator could have contributed to the corrosion observed.Per the event description, the pedal failure occurred during the procedure, preventing the footswitch from deactivating.Because the pedal became stuck after initial activation, the footswitch did not present the failsafe footswitch error alarm which would have prevented use of the footswitch.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: SERVICE REP FOOTSWITCH EP-1
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7234089
• Report Number: 1643264-2018-00094
• Device Sequence Number: 140173
• Product Code: HRX
• UDI-Device Identifier: 03596010251978
• UDI-Public: (01)03596010251978
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K892062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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: 7205396S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1