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

Catalog Number RLZB32

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary four pictures were provided; first and second pictures shows the velocity port and a lock end cut off from a gastric band.Third and fourth pictures shows a velocity port, gastric band, the lock end and the buckle tab cut off from the band, it appears to be cut as if it was intentionally.Based on the pictures alone no conclusion could be reached on how the reported event occurred.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.A batch history record review; an nc was created during the manufacturing of this batch but was not related to the event description.Additionally no defects related to the complaint were found during the manufacturing process.

Event Description

It was reported that the band was explanted at the patient¿s request due to gerd and dysphagia.The patient had also been suffering from problems from another procedure unrelated to the band.The surgeon was not the implant surgeon and did not have the date of implant other than to say, ¿six to seven years ago.¿ the strain relief does not appear in the photos provided.The surgeon was asked if there had been a port replacement after the band was implanted but he did not respond as he was not the implant surgeon and didn¿t seem to have historical information available.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• 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: 7458848
• MDR Text Key: 106587517
• Report Number: 3005075853-2018-09327
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 20705036004001
• UDI-Public: 20705036004001
• 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
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Catalogue Number: RLZB32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other