MAUDE Adverse Event Report: VALVE ON VP SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

A laparoscopic tissue sealer broke off when removing through a trochar.All pieces were found.Ethicon.Fda safety report id# (b)(4).

• Brand Name: VALVE ON VP SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• MDR Report Key: 10613477
• MDR Text Key: 209627944
• Report Number: MW5096999
• Device Sequence Number: 1
• Product Code: JXG
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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