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

Catalog Number SAGBX

Device Problems Disconnection (1171); Material Separation (1562)

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

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that a patient had gastric ring of mark sagb (swedish ring).Impossible to have the operating report or the exact references.The device is no longer functional due to a rupture of the catheter at the outlet of the adjustment chamber.The adjustment chamber has been removed.

Manufacturer Narrative

(b)(4).Date sent: 5/26/2023.D4: batch # unk.Attempts have been made to obtain the following information.To date a response has not been received.Should additional information be obtained, a follow-up report will be submitted.Implant date? has the patient had any adjustments or has the port been accessed? 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? how far is the tubing being pushed onto the port connector when connecting the port? to widest point on the port connector.Passed the widest point on the port connector.Is this the same technique used during original port implant? was the band explanted? what was the date of the explant? was there any patient consequence? 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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Manufacturer Narrative

(b)(4).Date sent: 10/13/2023.Additional information received: according to the email received from the surgeon, this complaint has already been reported in april 2023.Those details was captured under manufacturer report number 3005075853-2023-06192.Original event details from manufacturer report number 3005075853-2023-06192 are as follows: sagb ring catheter rupture problem.I took over a patient who underwent gastroplasty by adjustable ring in 2001 at the clinique de gentilly by dr a (b)(6) was carried out of which you will find attached a photo showing the device.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.New information received sep 14, 2023 by email from the surgeon : i followed up a patient who benefited from a gastroplasty using a modular ring in 2001.An eso-gastro-duodenal transit was carried out.It is impossible to retrieve the initial operating report and the ring references despite several attempts.No further information available.

Manufacturer Narrative

(b)(4).Date sent: 10/14/2023.

Manufacturer Narrative

(b)(4).Date sent: 11/30/2023.Additional information: this is an evaluation of an image sent by the account.Image: image named as ¿(b)(4) sagb mme g s (002).Fif, is an image from an x-ray film, in the image can be seen an implant of a gastric band, and the velocity port can be seen on the right side, no more details can be appreciated.As no more information is available, no conclusion could be reached as to the root cause of the reported issue.Because the instrument was not returned our evaluation is limited.

• 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: 17010491
• MDR Text Key: 316036189
• Report Number: 3005075853-2023-03564
• 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,Followup,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention