MAUDE Adverse Event Report: CONMED CORPORATION V-CARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number 60-6085-201

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2015

Event Type  malfunction  

Event Description

During davinci tlh, the doctor tried to use a medium v-care.He inserted the device into the uterus and blew up the balloon to hold it in place.It was discovered the balloon would not hold the air.At this time doctor removed the v-care and a new one was used.No harm to patient.

• Brand Name: V-CARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 5093882
• MDR Text Key: 26424646
• Report Number: 5093882
• 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
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 1503091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR