MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. REALIZE ADJ GASTRIC BAND STR; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problem Disconnection (1171)

Patient Problems Abdominal Pain (1685); No Code Available (3191)

Event Date 05/01/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.

Event Description

It was reported that after a realize band procedure in (b)(6) 2008 the patient complained of general abdominal pain.The patient had a revision procedure on (b)(6) 2010 because the tube had disconnected from the injection port.During this procedure, the port was replaced and the original tube was connected to the new port.The patient then had an explantation of the band and gastric sleeve procedure on (b)(6) 2016.Several months later, the patient notices that she can palpate what feels like an object in her abdomen.The patient then had a general surgery procedure on (b)(6) 2017 where the surgeon found a small plastic tube.This was later identified as a strain relief tube for the realize band.There has been no harm to the patient.It is unknown if the patient has continued to have general abdominal pain since the removal of the plastic tube.

Manufacturer Narrative

(b)(4).Additional information obtained: two pictures were provided; pictures provided shows the locking connector, a ruler can be seen that indicated about one centimeter of the connector.Based on the picture alone no conclusion could be reached on how the reported event occurred.

• Brand Name: REALIZE ADJ GASTRIC BAND STR
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7110348
• MDR Text Key: 94631000
• Report Number: 3005075853-2017-06683
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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 Catalogue Number: RLZB22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 01/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1