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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION V-CARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

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CONMED CORPORATION V-CARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 04/20/2021
Event Type  malfunction  
Event Description
Uterine manipulator came about into 3 sections when in use inside the patient.Fda safety report id # (b)(4).
 
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Brand Name
V-CARE
Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
CONMED CORPORATION
MDR Report Key11706230
MDR Text Key247130827
Report NumberMW5100934
Device Sequence Number1
Product Code LKF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/20/2021
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/21/2021
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 Age37 YR
Patient Weight86
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