MAUDE Adverse Event Report: ETHICON REALIZE GASTRIC BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problems Break (1069); Nonstandard Device (1420)

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

A 2 cm flexible sheath had broken off during removal of the realize gastric band.Please note there was a recall for this device for this same issue (recall number z-0289-2011).The removal of the gastric band occurred in 2014.Removal of the 2 cm flexible sheath was 21 months later.

• Brand Name: REALIZE GASTRIC BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON; 4545 creek rd.; cincinnati, OH 45242
• MDR Report Key: 5652284
• MDR Text Key: 45137912
• Report Number: 5652284
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RLZB32
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 109