MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problems Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 09/28/2022

Event Type  Injury  

Event Description

It was reported that during the cholecystectomy procedure, laparoscopic clip appliers would not fire the clips.There were no patient consequences.

Manufacturer Narrative

(b)(4).Batch # x94d6z.Additional information was requested and the following was obtained: spoke with surgeon on (b)(6).Surgeon let me know that the patient did have a post-op bile leak that they did have to address.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.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: 11/2/2022.Additional information was requested and the following was received: "were the clips visualized during the initial surgical procedure? no, the clips would not discharge how was the leak identified? it was identified through hida scan was a leak test performed? if so, what type and what was the result? no, according to the doctor there is no such thing.How many days postoperative did the leak occur? it was identified after 2 days how was the leak addressed? reoperation? laparoscopic lavage and a stent was placed if reoperation, was it open or laparoscopic? laparoscopic what was observed at the site of the leak upon reoperation? never identified- looked normal.What does surgeon believe caused the leak? cannot confirm the cause of the leak.Which firing of the device did this occur on? all of them.How was the initial procedure completed? as routine.Does the surgeon load the clips off of the vessel into the device jaws before applying the device jaws to the vessel and firing? did not during the case but does now.What is current patient status? leak was addressed and patient has been discharged.".

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• 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: 15674459
• MDR Text Key: 302428714
• Report Number: 3005075853-2022-07255
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: X94D6Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention