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

Catalog Number	60-6080-000A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During diagnostic laparoscopy for left cystectomy uterus perforation by vcare cannula.Direct visualization of uterus perforation with the laparoscope.Operator's remarks "handle is too rigid and the stopper doesn't prevent the manipulator from going in further".Fda safety report id# (b)(4).

• Brand Name: VCARE DX UTERINE MANIPULATOR
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 11700846
• Report Number: MW5100900
• Device Sequence Number: 3999143
• Product Code: LKF
• UDI-Device Identifier: 10653405003717
• UDI-Public: (01)10653405003717(17)230111(10)
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2023
• Device Catalogue Number: 60-6080-000A
• Device Lot Number: 202101111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Weight: 98