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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSAJET II CONSOLE; LAVAGE, JET

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SMITH & NEPHEW, INC. VERSAJET II CONSOLE; LAVAGE, JET Back to Search Results
Model Number 66800039
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 06/24/2016
Event Type  malfunction  
Event Description
It was reported that a versajet footswitch failed during surgery.
 
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Brand Name
VERSAJET II CONSOLE
Type of Device
LAVAGE, JET
Manufacturer (Section D)
SMITH & NEPHEW, INC.
970 lake carillon dr
st petersburg FL 33716
Manufacturer (Section G)
SMITH & NEPHEW ENDOSCOPY
76 s. meridian avenue
oklahoma city OK 73107
Manufacturer Contact
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key5949060
MDR Text Key55047291
Report Number3006760724-2016-00136
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/12/2016
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 Model Number66800039
Device Catalogue Number66800039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2016
Initial Date Manufacturer Received 09/12/2016
Initial Date FDA Received09/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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