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

Catalog Number 60-6085-201A,

Device Problems Break (1069); Inflation Problem (1310); Gas/Air Leak (2946)

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

Event Date 01/29/2019

Event Type  malfunction  

Event Description

During the period of (b)(6) 2019 to (b)(6) 2019 there were five instances of failed vcare devices in the operation room.Instance one and two: during robotic hysterectomy with bilateral salpingo-oophorectomy.The balloon on the vcare broke twice with catalog# 60-6085-201a; lot# 201812171 and 201811051.The third and fourth instance occurred during robotic hysterectomy with vcare balloon, which did not stay inflated, involved catalog# 60-6085-202a; lot# 201812261.The fifth instance occurred during a laparoscopic hysterectomy, which involved a vcare medium uterine manipulator catalog# 60-6085-201a; lot# 201901021, where the balloon leaked/failed to stay inflated.Several vcare devices were submitted to the manufacturer.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR, INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 8439248
• MDR Text Key: 139434271
• Report Number: 8439248
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-6085-201A,
• Device Lot Number: 201812171,201811051,201901021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Weight: 68