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

Catalog Number 60-6080-000A

Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  Injury  

Event 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
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 11700846
• MDR Text Key: 246779841
• Report Number: MW5100900
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003717
• UDI-Public: (01)10653405003717(17)230111(10)
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Catalogue Number: 60-6080-000A
• Device Lot Number: 202101111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 98