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U.S. Department of Health and Human Services

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

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CONMED CORPORATION VCARE MEDIUM UTERINE MANIPULATOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Model Number 60-6085-201A
Device Problem Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Event Description
Surgeon inflated balloon on device as part of the pre-use device check process, and the balloon would not deflate.Fda safety report id # (b)(4).
 
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Brand Name
VCARE MEDIUM UTERINE MANIPULATOR
Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
CONMED CORPORATION
MDR Report Key15043735
MDR Text Key296173228
Report NumberMW5110922
Device Sequence Number1
Product Code LKF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/14/2022
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 Expiration Date02/07/2024
Device Model Number60-6085-201A
Device Catalogue Number60-6085-201A
Device Lot Number202202071
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age34 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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