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

Model Number EL5ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed first day of month that complaint was reported.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 type of procedure did this occur during? what anatomical structure were the clips being placed on? how many days postoperative did the leak occur? how was the leak identified? how was the leak addressed? if reoperation, laparoscopic or open? what was observed at the site of the leak upon reoperation? were any malformed clips observed throughout patient care? how many clips is surgeon placing on patient? does the surgeon load the clips off of the vessel into the device jaws and visualize before applying the device jaws to the vessel and firing? what is current patient status?" 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.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.

Event Description

It was reported that after an unknown procedure, the clips were leaking.Patient came back and surgeon had to go back in.

Manufacturer Narrative

(b)(4).Date sent: 11/29/2022.Additional information was requested and the following was obtained: " what type of procedure did this occur during? lap chole.What anatomical structure were the clips being placed on? systic duct.How many days postoperative did the leak occur? 1 day.How was the leak identified? how was the leak addressed?wash out and drain.If reoperation, laparoscopic or open?1 reoperation, t.What was observed at the site of the leak upon reoperation? leak significant inflammation.Were any malformed clips observed throughout patient care? didn¿t appear to be.How many clips is surgeon placing on patient? 3.Does the surgeon load the clips off of the vessel into the device jaws and visualize before applying.The device jaws to the vessel and firing? yes.What is current patient status? both stable".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.

• 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: 15759801
• MDR Text Key: 303324138
• Report Number: 3005075853-2022-07701
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2022
• 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