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 Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Exact dates of band implant and explant unknown.Only the month (b)(4) and year (2012) of implant was provided.Only the year (2014) of explant date was provided.

Event Description

It was reported that the patient was implanted with the realized band in (b)(6) 2012.The patient elected to have the band removed in 2014, (exact date not provided), as she was not experiencing weight loss.In (b)(6) 2016, patient was to undergo hysterectomy procedure and pre-op imaging revealed a foreign body which was subsequently removed during the hysterectomy.Patient was asymptomatic prior to the procedure and no sequelae were reported related to the foreign body.

• 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: 7035438
• MDR Text Key: 93054662
• Report Number: 3005075853-2017-06139
• 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: company representative
• 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: ZMKBCK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2017
• 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