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

Model Number C-20360

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, it was reported that a port failure occurred.The surgeon stated that they do not wish to provide additional information.The sales rep was sent a picture via text message from the surgeon, which showed an explanted port for a lap-band w/ rapidport ez aps that had a fractured tubing at the junction point between the tubing and the port.No other details were provided about the incidence.On two (2) occasions, the rep asked the surgeon for the opportunity to meet up and discuss the incidence so further information can be gathered.The surgeon did not reply to either request.No further information about this incidence can be gathered.No additional information is available.

• 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: michelle ravert ; 1001 calle amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 13062826
• MDR Text Key: 285403409
• Report Number: 3013508647-2021-00044
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention