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

Catalog Number RLZB22

Device Problems Disconnection (1171); Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Diarrhea (1811); Dysphagia/ Odynophagia (1815); Nausea (1970); Foreign Body In Patient (2687)

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 12/8/2023.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.The following information has been requested.To date a response has not been received.Should additional information be obtained, a supplemental report will be submitted.What was the exact implant date? is the device still implanted or has it been removed? if removed, what date was it explanted? why was it removed? is it available to be returned for evaluation? is a lot or serial number available? who did the implant? explant? surgeon, resident, surgical assistant? was the patient experiencing a problem? if so, how did the patient present? what were the signs and symptoms? (e.G.Abdominal pain, redness/drainage at port site, fever, no restriction, etc.) has it been determined/confirmed that the patient¿s symptoms were directly related to the realize band? what is the current status of the patient? 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.

Event Description

It was reported that a patient had a band removed and had a retained foreign body.Device was implanted in 2008.No other details provided.

Manufacturer Narrative

(b)(4).Date sent: 12/12/2023.Additional information was requested and the following was obtained: implant date: (b)(6) 2008 is the device still implanted or has it been removed? device was removed on (b)(6) 2023, however retained foreign body discovered on (b)(6) 2023.We believe the foreign body is related to the 2010 fda recall ¿ on ct there was a 2cm tubular foreign body discovered near where the port site had been.Date explanted? (b)(6) 2023 is it available to be returned for evaluation? no, but the foreign body could be returned for evaluation when it is taken out.Is a lot or serial number available? yes, lot # zjjbnv and catalog # rlzb22.Who did the implant? (b)(6), md surgeon.Who did the explant? (b)(6) , md surgeon.Was the patient experiencing a problem? dysphagia and esophageal dysmotility if so, how did the patient present? patient presented with heartburn, sweating, nausea, diarrhea/constipation.Reported a lot of foods ¿make her sick.¿ reported she was unable to tolerate more than 2-3 bites of dense protein and intolerance of uncooked fruits/vegetables.Has it been determined/confirmed that the patient¿s symptoms were directly related to the realize band? yes, the esophageal dysmotility was related to the realize band what is the current status of the patient? she has requested that the foreign body be removed when she undergoes her next surgery for gastric bypass.The surgery has not been scheduled yet but she is undergoing further work up prior to scheduling the surgery.

• Brand Name: REALIZE ADJ GASTRIC BAND STR
• 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: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18291654
• MDR Text Key: 330150284
• Report Number: 3005075853-2023-09171
• 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
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Catalogue Number: RLZB22
• Device Lot Number: LOT # ZJJBNV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2008
• Type of Device Usage: Initial
• Patient Sequence Number: 1