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

Catalog Number C-20390

Device Problem Firing Problem (4011)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2023

Event Type  malfunction  

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 Description

Complaint provided by reshape sales representative : the port applier wasn't firing no other relevant information was provided.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: 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: 18339962
• MDR Text Key: 331053127
• Report Number: 3013508647-2023-00600
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Catalogue Number: C-20390
• Device Lot Number: 75GA4712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other