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

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Complaint reporter by employer: "during a lap-band removal, it was observed by the surgeon that the needle protection system had fractured, broken apart and traveled intraperitoneal while the white tubing remained intact and connected to the rapidport ez port.The dr notified me via text and i responded after receiving pictures of the explanted device." patient presented to surgery because of weight regain.

Manufacturer Narrative

Attempts to contact the physician for product return; however, product was not available to return for evaluation.Complaint could not be confirmed as product was not available for return analysis.No new risks identified, the current risk related to infection is in (b)(4) rev b with a low rate of occurrence for the reported complaint categories.Unable to determine root cause.A potential root cause was not determined.Complaint will be re-opened if product is returned for investigation.If additional information or product would be available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.

• 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: toan hoang ; 1001 calle amanecer; san clemente, CA 92673 ; 9492764349
• MDR Report Key: 15433118
• MDR Text Key: 304975894
• Report Number: 3013508647-2022-00144
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female