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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. FOOTSWITCH, MULTI-FUNCTION, VERSAJET II; LAVAGE, JET
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SMITH & NEPHEW MEDICAL LTD. FOOTSWITCH, MULTI-FUNCTION, VERSAJET II; LAVAGE, JET Back to Search Results
Catalog Number 66800472
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2020
Event Type  malfunction  
Event Description
It was reported that the foot pedal is damaged.No patient was involved.
 
Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and the insulation on the cord is torn and exposed wiring is visible.Functional inspection was performed and showed the footswitch will not activate motor in console.The complaint was confirmed and the root cause has been determined to be a damaged cord and internal wiring.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 complaint history review concluded this was a repeat issue.Smith and nephew will continue to monitor for any adverse trends relating to this product.
 
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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
MDR Report Key10763479
MDR Text Key213903799
Report Number8043484-2020-03362
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
PMA/PMN Number
K143115
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800472
Device Lot Number0804
Date Manufacturer Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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