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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
Catalog Number 66800039
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/24/2020
Event Type  malfunction  
Event Description
It was reported that there was a leak out of the handset connector slot.No patient was involved.
 
Manufacturer Narrative
H3, h6: the device intended for use in treatment was returned for evaluation.A relationship between the reported event and device could not be established.A visual inspection was performed and showed no damage.Functional inspection was performed and showed the device functioned as intended.Probable cause may be a connection issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found other related failures.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.
 
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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 HU3 2 BN
UK  HU3 2BN
MDR Report Key10411407
MDR Text Key203083297
Report Number8043484-2020-02514
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
PMA/PMN Number
K110958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Initial Date Manufacturer Received 07/24/2020
Initial Date FDA Received08/14/2020
Supplement Dates Manufacturer Received06/07/2021
Supplement Dates FDA Received06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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