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

Catalog Number	C-2365
Medical Device Problem Codes	Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient has the ap large band with 2.0 flex implanted the (b)(6) 2024.The patient was readmitted 24 days after post-op with food blockage (esophageal food impaction).The patient changed his diet prematurely.The patient was admitted to the emergency room and had a prolonged esophagogastroduodenoscopy (egd) to remove the food blockage (food disimpaction).
Additional Manufacturer Narrative
The reported device was not available for physical evaluation as the device is still implanted.The reporter provided the serial number of the device involved.The lot history record was reviewed, and no discrepancies or non-conformances were recorded.The product was manufactured according to specifications.The cause of the food blockage (esophageal food impaction) was due to the patient prematurely self-advancing his post-op diet.No further action to be taken unless we receive more information from the doctor.No new risks identified, the current risk is identified with a low rate of occurrence for the reported complaint categories.No correction or corrective action required.Note: only the year and the month for the implanted date were provided by the reporter.Only the month and the year for the event date were provided by the reporter.

• Brand Name: LAP-BAND SYSTEM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 18 technology drive, suite 110; irvine CA 92618
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 18 technology drive, suite 110; irvine CA 92618
• Manufacturer Contact: maria quiroz ; 18 technology drive, suite 110; irvine, CA 92618 ; 8449377374
• MDR Report Key: 20589003
• Report Number: 3013508647-2024-00063
• Device Sequence Number: 15652651
• Product Code: LTI
• UDI-Device Identifier: 00850007764654
• UDI-Public: 00850007764654
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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 Expiration Date: 02/06/2025
• Device Catalogue Number: C-2365
• Device Lot Number: 75GB8334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male