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

Model Number C-20304

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2021

Event Type  malfunction  

Event Description

Port tubing broken at that junction of the stainless steel connector.This event caused no additional treatment.

• Brand Name: LAP BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer (Section G): APOLLO ENDOSURGERY; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: brian stowe ; 1001 calle amanecer; san clemente, CA 92673 ; 9494817801
• MDR Report Key: 11464011
• MDR Text Key: 243728626
• Report Number: 3013508647-2021-00008
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-20304
• Device Catalogue Number: C-20304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 64 YR