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

Model Number 60-6085-201A

Device Problem Inflation Problem (1310)

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

Event Date 04/24/2019

Event Type  malfunction  

Event Description

Conmed corporation, vcare medium, vaginal-cervical-ahluwalias-retractor-elevator, balloon would not stay inflated.Prior to the start of the procedure, the balloon was tested per protocol, at which time the defect was discovered.Fda safety report id # (b)(4).

• Brand Name: VCARE MEDIUM UTERINE MANIPULATOR
• Type of Device: CANNULA, MANIPULATOR/ INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 8555217
• MDR Text Key: 143462309
• Report Number: MW5086192
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2021
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201903181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR