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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION MANIPULATOR UTERINE VCARE RETRAC; CANNULA, MANIPULATOR/INJECTOR, UTERINE

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CONMED CORPORATION MANIPULATOR UTERINE VCARE RETRAC; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Model Number 60-6085-200
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
Manipulator uterine vcare retractor small 60-6085-200: upon removal of the small v-care from the vagina, it was noted that both the balloon and the green cup came off.Fda safety report id # (b)(4).
 
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Brand Name
MANIPULATOR UTERINE VCARE RETRAC
Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
CONMED CORPORATION
MDR Report Key12108382
MDR Text Key260147586
Report NumberMW5102269
Device Sequence Number1
Product Code LKF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/29/2021
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 Model Number60-6085-200
Device Catalogue Number60-6085-200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/01/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age74 YR
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