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	02/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foot pedal was sticky, they pulled the shaver out of the knee and it was still running.
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.
Additional Manufacturer Narrative
Investigator determined no relationship found between the returned device and the reported incident.Complaint of footswitch pedal getting stuck and shaver still running was not confirmed.The right pedal spring still works but does not activate shaver when depressed.The right pedal is nonfunctional.Cause of pedal malfunction is extreme corrosion and moisture inside of chassis.Corrosion and moisture has disabled the actuator causing right pedal malfunction.The complaint investigation has concluded the cause of the identified failure to be a corroded switch/actuator on the right pedal of 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.A visual inspection was performed on the product and the lid was scratched.

• 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: 7303424
• Report Number: 1643264-2018-00177
• Device Sequence Number: 1090929
• 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: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2018

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: 04/17/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/12/2018; 04/12/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/16/2018; 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1