MAUDE Adverse Event Report: ETHICON-ENDOSURGERY, INC. REALIZE; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Tissue Damage (2104)

Event Date 01/31/2016

Event Type  Injury  

Event Description

Patient underwent removal of realize band system, which had been originally placed 8 years ago.The procedure was completed without complications and patient discharged to home same day.Postoperatively, patient had persistent abdominal pain.Ct scan of abdomen revealed a "likely retained lap band tubing." patient returned to operating room 19 days later and underwent extraction of retained foreign body.After probing the wound, electrocautery was used as the object was lodged in the rectus muscle.After removal of surrounding tissue, the object was identified as a realize band connector.The patient tolerated the procedure well and was discharged the following day.

• Brand Name: REALIZE
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON-ENDOSURGERY, INC.; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 5479826
• MDR Text Key: 39652072
• Report Number: 5479826
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2016
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR