MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Model Number ER420

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Failure to Anastomose (1028)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed first day of month that complaint was reported.Batch #: unknown.Additional information was requested and the following was obtained: "how was the initial procedure completed? yes.Were there any difficulties with the device and/or clip formation during the initial procedure? unknown.What was the diameter of the duct that was closed? unknown.How many days after the initial procedure did the leak occur? unknown.How was the leak identified? unknown.What was observed at the site of the leak during reoperation? unknown.Were any malformed or scissored clips observed at the site of the leak during the reoperation? unknown.What does the surgeon believe caused the leak? the clip.What is current patient status? surgeon said patient is fine".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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Event Description

It was reported that during an unknown procedure, the surgeon stated a patient had a bile leak after using the device.Unknown if the procedure was completed successfully.There were adverse consequences for the patient.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15986240
• MDR Text Key: 305498432
• Report Number: 3005075853-2022-08649
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 40705036012598
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention