MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has not been provided.If further details are received at a later date a supplemental medwatch report will be sent: please verify the product code? what was the issue with the device? did the patient have any complications while the band was implanted? what was the implant date?.

Event Description

It was reported that the surgeon was removing the realize band and the cuff broke off in the subcutaneous layer of the skin.It was located and removed.The patient was not happy with the results of the band and as a result had it removed with no complications.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9582902
• MDR Text Key: 202549982
• Report Number: 3005075853-2020-00286
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2019

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: SAGBX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1