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

Model Number EL5ML

Device Problem Insufficient Information (3190)

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

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy procedure that the device mis-fired numerus times.No further information was provide.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Batch # v9628t.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device was returned with no damage in the external components; upon visual inspection, three clips were noted to be jammed.The clips were removed in order to perform functional testing.Upon testing, the device was fired, and the clips did not advance into the jaw.The device was noted to have the tip of the advancer bent.The instrument was disassembled, upon disassembly the advancer was confirmed to be bent and 10 clips were found inside clip track.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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.Please reference the instruction for use for more information.Additional information was requested, and the following was obtained: please clarify how the device ¿misfired¿.Did device not feed clips? did device feed clips sideways? did device not fire clips (jammed)? did device fire malformed clips? did device fire scissored clips? did device drop or eject clips? if other, please specify answer= i do not have any more information on how the device misfired.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.

• 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 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15188152
• MDR Text Key: 304973195
• Report Number: 3005075853-2022-05143
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• 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: V9628T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1