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.; VERSAJET EXACT ASSY, 45 DEGREE X 14MM
  • 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.; VERSAJET EXACT ASSY, 45 DEGREE X 14MM Back to Search Results
Model Number VERSAJET EXACT ASSY, 45 DEGREE X 14MM
Device Problems Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2020
Event Type  malfunction  
Event Description
It was reported that during debridement the handpiece was replaced and the surgery continued because it felt like the water flow was weakening.No harm was done to the patient and there was no delay.
 
Manufacturer Narrative
The device, which was used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed on the exterior no defects were found.The functional testing confirmed the pump flow test failed to prime, this could due to blockage and corrosion confirmed within the fitting and chambers.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported event however this investigation is now complete with no further action deemed necessary at this stage.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
VERSAJET EXACT ASSY, 45 DEGREE X 14MM
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK  HU3 2BN
MDR Report Key10130057
MDR Text Key194385541
Report Number8043484-2020-00671
Device Sequence Number1
Product Code FQH
UDI-Device Identifier04582111153555
UDI-Public4582111153555
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVERSAJET EXACT ASSY, 45 DEGREE X 14MM
Device Lot Number50803066
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-