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

Device Problem Fracture (1260)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 08/13/2022

Event Type  malfunction  

Manufacturer Narrative

No investigation was performed.No information available regarding the product that was involved.Unable to determine root cause or conduct trending analysis.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.The lot history record for the complaint was not available to be reviewed.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

Event Description

Patient presented to surgery because of return of reflux and weight regain.Complaint observed by employee / reporter: "observed a lap-band removal w/ conversion to roux-en-y gastric bypass (rygb) on saturday (b)(6) 22 @ approx.1:30pm.During case i observed that the device appeared to have fractured just proximal to the end connector." the device is not available to be returned (requested, but or team had already disposed).

• 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: maria quiroz ; 1001 calle amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 15414888
• MDR Text Key: 304894720
• Report Number: 3013508647-2022-00140
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2022
• Initial Date FDA Received: 09/13/2022
• 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): Required Intervention
• Patient Sex: Female