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

Model Number	60-6085-201
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upon removing the conmed medium v-care uterine manipulating retractor from the vagina, it fell apart.It is not meant to disassemble.The cervix with uterus attached was secured to the green size 34mm cervical cup of the v-care as per procedure/ surgical norm.This green cup fell apart from the blue obturator/ manipulator.Device was removed from service and all pieces were obtained.The specimen was also removed successfully with no harm to the patient and no delay in procedure.

• Brand Name: VCARE MEDIUM
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 9896971
• Report Number: 9896971
• Device Sequence Number: 16700585
• Product Code: LKF
• UDI-Device Identifier: 30653405061803
• UDI-Public: (01)30653405061803
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020
• Report Date (Section F): 03/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: 60-6085-201
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201911250
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 93
• Date Report Sent to FDA: 03/03/2020