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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION VCARE SMALL VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE
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CONMED CORPORATION VCARE SMALL VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Model Number 60-6085-200A
Device Problems Disconnection (1171); Entrapment of Device (1212)
Patient Problem Insufficient Information (4580)
Event Date 06/01/2021
Event Type  malfunction  
Event Description
While trying to remove uterus, the distal portion of the vcare, including the green cup and blue balloon, became disconnected from the handle and remained inside the patient while the handle was pulled away from the vagina.The uterus was still inside the patient as well as the disconnected parts (green cup and blue balloon tip).Physicians quickly worked to remove the remaining objects from the patient.We were able to assess an intact vcare and disassemble it off the field and confirm that all parts were successfully removed from the patient.Fda safety report id # (b)(4).
 
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Brand Name
VCARE SMALL VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR
Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
CONMED CORPORATION
MDR Report Key11957212
MDR Text Key255134373
Report NumberMW5101751
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 06/04/2021
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 Expiration Date01/12/2023
Device Model Number60-6085-200A
Device Lot Number202101121
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/07/2021
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
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