MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC REALIZE C ADJUSTABLE LAPBAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number RLZ832

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

Patient has realize c gastric band placed approximately four years ago by surgeon.Patient came to surgery today to have band removed and conversion to sleeve gastrectomy.When surgeon entered the abdomen, the band tubing was not connected to the port, it was found free floating in the abdomen.Surgeon was unable to identify (find) the small plastic connecting piece.

• Brand Name: REALIZE C ADJUSTABLE LAPBAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 3786082
• MDR Text Key: 4359560
• Report Number: 3786082
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/30/2014

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: Physician
• Device Model Number: RLZ832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 115