MAUDE Adverse Event Report: CONMED CORPORATION V-CARE RETRACTOR-ELEVATOR; CANNULA, MANIPULATOR, INJECTOR

Model Number REF 60-6085-200A

Device Problem Inflation Problem (1310)

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

Event Date 08/29/2018

Event Type  malfunction  

Event Description

V-care balloon would not inflate.

• Brand Name: V-CARE RETRACTOR-ELEVATOR
• Type of Device: CANNULA, MANIPULATOR, INJECTOR
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 8428455
• MDR Text Key: 139180304
• Report Number: MW5084973
• 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: Other
• 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: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: REF 60-6085-200A
• Device Lot Number: 201710301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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