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

Model Number C-2360

Device Problems Complete Blockage (1094); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The patient had the band placed on (b)(6) 2019.The patient went into to see the physician for the initial adjustment and there was no band restriction.The physician confirmed there was a leak and the patient is requesting a revision surgery.

Manufacturer Narrative

Complaint could not be confirmed as a leak was not able to be reproduced prior to and after decontamination.The septum was partially dislodged from the metal retaining ring in the port, but did not leak.There is an internal blockage in the port and does not allow fluid to be added or removed from the port.The lhr for the port was reviewed and no discrepancies or non-conformances recorded.Product was manufactured to specification.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente, ca
• MDR Report Key: 9916414
• MDR Text Key: 191404906
• Report Number: 3013508647-2020-00019
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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 Expiration Date: 06/07/2021
• Device Model Number: C-2360
• Device Catalogue Number: C-2360
• Device Lot Number: AF02919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1