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

Model Number 60-6085-201

Device Problem Inflation Problem (1310)

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

Event Date 06/23/2016

Event Type  malfunction  

Event Description

Balloon on vcare would not stay inflated when dr placed it for robotic hysterectomy.A second one was obtained and it stayed inflated as expected manufacturer response for vcare disposable uterine manipulator, conmed (per site reporter): vcare disposable uterine manipulator.

• Brand Name: CONMED
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502
• MDR Report Key: 5842685
• MDR Text Key: 51017888
• Report Number: 5842685
• 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: 07/12/2016,07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/11/2018
• Device Model Number: 60-6085-201
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201604111
• Other Device ID Number: MEDIUM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1