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

Catalog Number 60-6085-201A

Device Problems Bent (1059); Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2016

Event Type  malfunction  

Event Description

During hysterectomy, vcare manipulator was difficult to use.Upon removal, it was noted that the handle was bent.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd.; utica NY 13502
• MDR Report Key: 6249266
• MDR Text Key: 64751065
• Report Number: 6249266
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201608311
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR