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

Catalog Number SAGBX

Device Problem Disconnection (1171)

Patient Problems Failure of Implant (1924); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Sagb ring catheter rupture problem.I took over a patient who underwent gastroplasty by adjustable ring in 2001 at the (b)(6) by dr.A togd was carried out.The catheter broke at the exit of the adjustment box which had to be removed for painful phenomena.The end of the catheter is currently free in the abdominal cavity responsible for some painful phenomena.The patient would like her ring to be put back into service.

Manufacturer Narrative

(b)(4).Date sent: 8/29/2023, d4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Attempts are being made to obtain the following information.To date a response has not been received.Should a response be received, a supplemental report will be submitted.What is the implant date? what is the exact product code? how was the port disconnect detected? is this first incident of port disconnection? is the locking connector attached to the port? was it locked? where was the strain relief? what action was taken to address the issue? what is the current status of the patient? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 10/13/2023.Additional information received: according to the email received from the surgeon, this complaint had already been reported in (b)(6) 2023.That event was captured on manufacturer report number 3005075853-2023-03564.This event is a duplicate of manufacturer report number 3005075853-2023-03564.Any further information obtained regarding this event will be captured on manufacturer report number 3005075853-2023-03564.G8 - manufacturer report number = 3005075853-2023-03564.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17641622
• MDR Text Key: 322165065
• Report Number: 3005075853-2023-06192
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention