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

Model Number 7205396S

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2018

Event Type  malfunction  

Event Description

It was reported that the foot pedal was sticky, they pulled the shaver out of the knee and it was still running.

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.

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
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7303424
• MDR Text Key: 101347550
• Report Number: 1643264-2018-00177
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010251978
• UDI-Public: (01)03596010251978
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1