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

Model Number C-20360

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/10/2020

Event Type  malfunction  

Event Description

Leak from the port connector where tubing was joined and separated due to the tube having been stressed by sharp angulation.Port removed.System flushed.Port replaced.Patient attended nhs xray which showed disconnection of tubing.

Manufacturer Narrative

Investigation summary: the reported complaint for leak and broken strain relief were confirmed.The cause of the leak was a hole in the tubing at the port stem likely caused by the detachment of the strain relief.The cause of the detached strain relief is a deformed port connector.The cause of the deformation was not determined.

• Brand Name: LAP BAND SYSTEM
• Type of Device: ADJUSTABLE GATRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 11389521
• MDR Text Key: 239131292
• Report Number: 3013508647-2021-00005
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

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
• Device Operator: Health Professional
• Device Model Number: C-20360
• Device Catalogue Number: C-20360
• Device Lot Number: 37GE1517
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/27/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 96