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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. LAVAGE, JET; VERSAJET II CONSOLE Back to Search Results
Model Number 66800039
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported customer could not seat key into keyhole and therefore could not turn the key.
 
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Brand Name
LAVAGE, JET
Type of Device
VERSAJET II CONSOLE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
970 lake carillon drive
st petersburg FL 33716
Manufacturer (Section G)
SMITH & NEPHEW ENDOSCOPY
76. s meridan avenue
oklahoma city OK 73107
Manufacturer Contact
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key5983244
MDR Text Key56114399
Report Number3006760724-2016-00144
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 user facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/16/2016
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
Device Lot NumberKWEC120034
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/26/2016
Initial Date FDA Received09/28/2016
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 Initial
Patient Sequence Number1
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