MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was implanted with a realize band on (b)(6) 2010.The patient elected to have the band removed and convert to a roux-en-y on (b)(6) 2011.Later, the patient was undergoing an unrelated surgical procedure when the strain relief was discovered.The patient was asymptomatic prior to the procedure and the strain relief was an incidental finding at that time as no sequelae were reported related to the strain relief.

• Brand Name: NA
• 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: 7031122
• MDR Text Key: 92843057
• Report Number: 3005075853-2017-06115
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial

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: RLZB32
• Device Lot Number: ZMKPBB6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 11/14/2017
• 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