MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. FOOTSWITCH, MULTI-FUNCTION, VERSAJET II; LAVAGE, JET

Catalog Number 66800472

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the foot pedal is not working, it is unknown what happened.No patient was involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.The footswitch passed functional testing.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process, establishing no relationship between the device and the reported event.The probable causes may include a connection issue and or a component failure.A review of the manufacturing records found that there was no evidence that the product didn't meet specifications at the time of manufacture.A complaint history review found further instances of the reported events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include a connection issue and or a component failure.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: FOOTSWITCH, MULTI-FUNCTION, VERSAJET II
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11713280
• MDR Text Key: 246960204
• Report Number: 8043484-2021-00932
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1