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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 Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2020
Event Type  malfunction  
Event Description
It was reported that during set up/inspection the device failed to prime.The sample will not be returned because it was discarded in the hospital due to the contact-infected patient.
 
Manufacturer Narrative
The device that was intended for use in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.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 other related failures.Probable cause may be an obstruction or component failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Smith and nephew will continue to monitor for any adverse trends relating to this product.No further investigation is required.
 
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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 Key10241522
MDR Text Key197911161
Report Number8043484-2020-01740
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,foreig
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800041
Device Lot Number50808825
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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