Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. FOOTSWITCH, MULTI-FUNCTION, VERSAJET II; LAVAGE, JET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW MEDICAL LTD. FOOTSWITCH, MULTI-FUNCTION, VERSAJET II; LAVAGE, JET Back to Search Results
Catalog Number 66800472
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  malfunction  
Event Description
It was reported that, foot pedal was not recognized by versajet ii power console.A replacement foot pedal was tested and functioned properly.No case involved; therefore, no patient involvement.
 
Manufacturer Narrative
The device, intended for use 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 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11683375
MDR Text Key245994831
Report Number8043484-2021-00858
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 company representative,health
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800472
Was Device Available for Evaluation? No
Date Manufacturer Received07/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-