MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CUR.ADJ.BAND WITH PORT+APPLIER; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problems Disconnection (1171); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/30/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/25/2023.D4: batch#: unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the implant date? upon removal, was 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? an evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the device was removed from the patient on (b)(6) 2011.The patient came back to the hospital for the ablation of a subcutaneous foreign body at the abdominal level on (b)(6) 2023.During the intervention, the surgeon found a part of the device.

Manufacturer Narrative

(b)(4).Date sent: 11/21/2023.Investigation summary : the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that only a tubbing strain relief of the bd3xv device was returned.No functional testing could be performed.No conclusion could be reached as to how the tubbing strain relief issue occurred.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number zjnbgl, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 10/20/2023.Additional information received: information provided by the customer on 21 sept 2023: the removed part seems to be a connection fitting between the tubing and ring case.This piece is in clear silicon, which explains that during the extraction of the case and the ring, this part, which was deeply buried at the bottom of an important subcutaneous thickness, could not be detected by the surgeon who retrieved the ring and performed the conversion to a by-pass.The surgeon interrogates about the relevance of colorlessness of this element from the device.

• Brand Name: CUR.ADJ.BAND WITH PORT+APPLIER
• 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: 17628654
• MDR Text Key: 322020692
• Report Number: 3005075853-2023-06129
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: BD3XV
• Device Lot Number: ZJNBGL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2009
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention