MAUDE Adverse Event Report: CONMED CORPORATION VCARE SMALL, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR; UTERINE MANIPULATOR / INJECTOR

Model Number 60-6085-200A

Device Problem Inflation Problem (1310)

Patient Problem No Information (3190)

Event Date 03/19/2019

Event Type  malfunction  

Event Description

Conmed corp., vcare small, vaginal-cervical-ahluwalia's-retractor-elevator, uterine manipulator balloon would not inflate.

• Brand Name: VCARE SMALL, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR
• Type of Device: UTERINE MANIPULATOR / INJECTOR
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 8439785
• MDR Text Key: 139576578
• Report Number: MW5085060
• Device Sequence Number: 0
• Product Code: LKF
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 201901141
• 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: 57 YR