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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; LAVAGE, JET
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SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; LAVAGE, JET Back to Search Results
Model Number 66800039
Device Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2021
Event Type  malfunction  
Event Description
It was reported that the versajet ii console warning light flashed.No case was involved.
 
Manufacturer Narrative
The device, intended for use in treatment was returned for evaluation.A relationship between the reported event and device could be established.A visual inspection was performed on the exterior of product and no physical damage was observed.Functional inspection was performed and showed the complaint of error led activated was confirmed.The root cause has been determined to be loose wires.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint review indicated other failures reported.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.
 
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Brand Name
VERSAJET II CONSOLE
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 Key11574782
MDR Text Key242418836
Report Number8043484-2021-00681
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00040565124759
UDI-Public00040565124759
Combination Product (y/n)N
PMA/PMN Number
K110958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number66800039
Device Catalogue Number66800039
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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