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

Model Number C-20360

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/23/2020

Event Type  malfunction  

Event Description

Tubing had already broken off at the connector and thus had dropped into the abdomen.Laparoscopy with the retrieval of tubing.(b)(6) 2020 volume check performed and 0cc found in band.Patient confirmed no resistance felt, volume checks followed.Xray performed and leak identified.

Manufacturer Narrative

Complaint for leak could not be confirmed as a leak was not able to be reproduced prior to and after decontamination.Complaint for detached strain relief is confirmed.The production records for the port was reviewed and no discrepancies or non-conformances recorded.Product was manufactured to specification.Unable to determine root cause.

• Brand Name: LAP BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 11385913
• MDR Text Key: 239121555
• Report Number: 3013508647-2020-00041
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2019
• Device Model Number: C-20360
• Device Catalogue Number: C-20360
• Device Lot Number: AF01360
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 112