MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problems Achalasia (1692); Erosion (1750); Dysphagia/ Odynophagia (1815); Ischemia (1942); Nausea (1970); Pain (1994); Sepsis (2067); Obstruction/Occlusion (2422); Weight Changes (2607); Gastrointestinal Regurgitation (4477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing, and as additional information becomes available including whether or not the devices identified in the published article were lap-band, a supplemental report will be made.At this time, the reported issue will be tracked and trended.H6: health effect - clinical code - code 4581 used to identify that codes for insufficient weight loss, loss of satiety and esophageal dilatation do not exist.

Event Description

Literature review performed: managing complications of bariatric surgery richard m.Peterson, md, mph(a), john d.Scott, md(b) (a) - 7703 floyd curl drive, mail code 7842, san antonio, tx 78229-3900, usa; (b) - 905 verdae boulevard, suite 202, greenville, sc 29607, us advances in surgery 53 (2019) 55-68 https://doi.Org/10.1016/j.Yasu.2019.04.004 published 15may2019.This published article describes how to manage complications of bariatric surgery that a general surgeon may face at some time in their career.It describes three scenarios for lagb related to slippage, erosion and esophageal dilitation.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: jazmin quiroz ; 1001 calle amanener; san clemente, CA 92673 ; 8779377374
• MDR Report Key: 16993522
• MDR Text Key: 315864570
• Report Number: 3013508647-2023-00372
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other