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

Catalog Number	RLZB32
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7458848
• Report Number: 3005075853-2018-09327
• Device Sequence Number: 11035951
• Product Code: LTI
• UDI-Device Identifier: 20705036004001
• UDI-Public: 20705036004001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other