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

Model Number 7205396S

Device Problem Sticking (1597)

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

Event Date 04/05/2018

Event Type  malfunction  

Event Description

It was reported that the footswitch was sticking, causing that the shaver blade was running continuously.No patient injuries were reported.

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,
• 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: 7530013
• MDR Text Key: 108941573
• Report Number: 1643264-2018-00390
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• 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: 7205396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• 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