MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. REALIZE ADJ GASTRIC BAND-C; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2022

Event Type  Injury  

Event Description

It was reported that the patient had the realize band implanted on (b)(6) 2009 and it is causing excessive acid reflux.It was rated a b.The device has caused lose of their voice many times.

Manufacturer Narrative

(b)(4).An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information obtained: the band was originally implanted on (b)(6) 2009.It was explanted (b)(6) 2022.Information provided just indicates it was a realize band, no product code or lot number provided.The patient had several refills/adjustments from both surgeons.The exact number of adjustments and their amounts were not provided.The exact volume of fluid in the band was not provided.The patient had the band removed due to dysphagia and reflux.No information was provided on testing performed to diagnose the issue.The patient was having severe gerd symptoms which resolved after the band was removed.She indicated they were never able to fully deflate the band.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 10/26/2022.Op reports.

Manufacturer Narrative

(b)(4) date sent: 10/19/2022 investigation summary the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the rlzb32 device was returned with, curve band ( etch # 20191386) and the one-way valve connected, the velocity port ( etch # 20-16-64-08) with locking connector, tubing strain relief, and 7 cm of the catheter, 3 punctures were present on the septum.The buckle was noted to be broken, no suture was present, and 1 hook was damaged.Due to the returned condition of the hook, no functional test can be performed on the velocity port, however, this is not related to the reported condition of patient related issues.No conclusion could be reached as to what caused the patient related issues.As part of the ethicon endo-surgery quality process, all devices are manufactured, inspected, and released to approved specifications.Lot zkjbhy, man date; 8/20/2009 exp date; 7/31/2014 lot zkjbhz man date; 8/20/2009 exp date; 7/31/2014 lot zkkbb3 man date; 9/03/2009 exp date; 8/31/2014 d1, d2 and d4.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15303568
• MDR Text Key: 298713710
• Report Number: 3005075853-2022-05581
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/22/2022; 10/19/2022
• Supplement Dates FDA Received: 10/19/2022; 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention