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

Model Number 66800472

Device Problem Defective Component (2292)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that, the food pedal of a footswitch, multi-function, versajet ii was not functioning properly and would not control device.As this happened in a marketing demonstration, there was not patient involvement.

Manufacturer Narrative

The device intended for use in treatment was returned for evaluation.A visual inspection was performed and showed bare wiring visible near strain relief.Functional inspection was performed and showed the device functioned as intended which could not establish a relationship between the device and reported event.Probable root cause may include an intermittent component failure or a connection issue.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 other related failures.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for adverse trends related to this product.

• Brand Name: FOOTSWITCH, MULTI-FUNCTION, VERSAJET II
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12439986
• MDR Text Key: 270334059
• Report Number: 8043484-2021-01716
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565125473
• UDI-Public: 00040565125473
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800472
• Device Catalogue Number: 66800472
• Device Lot Number: 03619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• 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: Unknown
• Patient Sequence Number: 1