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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 14MM; LAVAGE, JET
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SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 14MM; LAVAGE, JET Back to Search Results
Catalog Number 66800041
Device Problem Failure to Prime (1492)
Patient Problem No Information (3190)
Event Date 08/17/2020
Event Type  malfunction  
Event Description
It was reported that the handpiece didn¿t want to prime.
 
Manufacturer Narrative
The device, was not used in a procedure was not returned for evaluation with all additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.No batch /lot number has been provided rendering a review of the device history not possible.A complaint history review found other related failures.Probable cause may be an obstructed fluid supply.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
 
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Brand Name
VERSAJET EXACT ASSY, 45 DEGREE X 14MM
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 Key10518861
MDR Text Key206476953
Report Number8043484-2020-02827
Device Sequence Number1
Product Code FQH
UDI-Device Identifier04582111153555
UDI-Public4582111153555
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,foreig
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800041
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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