MAUDE Adverse Event Report: CONMED CORPORATION VCARE; UTERINE MANIPULATOR

Model Number 60-6085-201

Device Problem Inflation Problem (1310)

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

Event Date 09/25/2015

Event Type  malfunction  

Event Description

A v-care uterine manipulator was inserted into the vagina.The balloon that is to be inflated to retain it in the vagina inflated and then spontaneously deflated.The balloon would not stay inflated.The v-care was removed and a new one was inserted.The balloon on the new v-care was functional.There was no injury to the patient, only a minor delay in starting the case.

• Brand Name: VCARE
• Type of Device: UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica, NY 13502
• MDR Report Key: 5079887
• MDR Text Key: 25910176
• Report Number: 5079887
• 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: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/08/2017
• Device Model Number: 60-6085-201
• Device Lot Number: 201505081
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2015
• 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
• Patient Age: 45 YR
• Patient Weight: 63