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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 Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2019
Event Type  malfunction  
Event Description
It was reported that during a case, a handset was opened and the nurse was unable to turn the handset to the lock position.The handset connector was locked up.The doctor proceeded with the case without the use of versajet ii.The console needs to be replaced.
 
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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
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK   HU3 2BN
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
4407940038
MDR Report Key9446804
MDR Text Key170134449
Report Number8043484-2019-00898
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/10/2020
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 No Information
Device Catalogue Number66800039
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received12/10/2019
Supplement Dates Manufacturer Received12/09/2020
Supplement Dates FDA Received12/10/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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