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

Model Number EL5ML

Device Problems Insufficient Information (3190); Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: u93m5r.Date of event is 2021.Event day and event month were not reported.(b)(4).Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.A tyvek was returned along with the device.Upon visual analysis of the returned sample, it was determined that the el5ml device was received with one jaw disengaged from the cam, and the cam was noted bent from the right side.This condition would not allow the jaws to collapse in order to form the clips.No functional test was performed due the condition of the device.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembly, the advancer was noted bent and six clips were found inside clip track.The event reported was confirmed and it is related to improper use of the device.Please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse, could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.Possible causes for the condition of the jaw disengagement from the cam may be due to inadvertent force, twisting, or pressure being placed on the device jaws, using the jaws of the device as a dissector/retractor, or damage to the jaws while entering the trocar.Please reference the instructions for use for more information.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the el5ml was hard to fire and clips deflected.It is unknown how the procedure was completed.There was no patient consequence.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• 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 ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12005243
• MDR Text Key: 256526432
• Report Number: 3005075853-2021-03342
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: U93M5R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1