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

Catalog Number	C-20390
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint could not be analyzed as product was not available for return analysis.The lot history record associated with the complaint was reviewed and no discrepancies or non-conformances associated with the firing issue recorded.Product was manufactured and sterilized according to specification.Unable to determine root cause or conduct trending analysis.No further action to be taken unless the patient responds with more information.No new risks identified.No correction or corrective action required.
Event or Problem Description
Complaint provided by reshape sales representative : the port applier wasn't firing no other relevant information was provided.
Additional Manufacturer Narrative
Providing the udi information.

• Brand Name: LAP-BAND SYSTEM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 7625 golden triangle drive; suite g; eden prairie MN 55344
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 7625 golden triangle drive; suite g; eden prairie MN 55344
• Manufacturer Contact: maria quiroz ; 7625 golden triangle drive; suite g; irvine, MN 55344 ; 8449377374
• MDR Report Key: 18339962
• Report Number: 3013508647-2023-00600
• Device Sequence Number: 6740483
• Product Code: LTI
• UDI-Device Identifier: 00850007764906
• UDI-Public: 0100850007764906172401061075GA471
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2024
• Device Catalogue Number: C-20390
• Device Lot Number: 75GA4712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown