MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON GASTRIC BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number RLZB32

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

Removal of retained foreign body status post removal of ethicon gastric band model# rlzb32 lot# zmfbbf.Diagnostic laparoscopy removal of foreign body.

• Brand Name: ETHICON GASTRIC BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; mw#39; cincinnati OH 45242
• MDR Report Key: 19089561
• MDR Text Key: 340103622
• Report Number: MW5153743
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2024

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: RLZB32
• Device Lot Number: ZMFBBF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White