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

Model Number C-20304

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

Unable to observe a blockage in the items returned for inspection.Air and fluids flow freely between the port and all tubing examined.No leaks were observed in the port or tubing.Could not replicate the failure reported as the port functioned correctly.No new risks identified, the current risk for this complaint category 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 port lot was reviewed and no discrepancies or non-conformance's recorded.Product was manufactured according to specification.Unable to determine root cause.A potential root cause was not determined.

Event Description

Port was implanted and when surgeon went to fill the band, the port was blocked.Replaced with another port which worked fine.

• 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: brian stowe ; 1001 calle amanecer; san clemente, CA 92673 ; 9494817801
• MDR Report Key: 11925531
• MDR Text Key: 264995266
• Report Number: 3013508647-2021-00020
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: C-20304
• Device Catalogue Number: C-20304
• Device Lot Number: AF04156
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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