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 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # x9416m.Investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the el5ml device was returned with the orange indicator that appears on the top of the handle and the handle was noted partially open from the orange indicator area to the proximal end of the device.In addition, a tyvek was received along with the device.Upon visual inspection, three overlap clips were noted to be jammed inside the shaft.The clips were removed in order to perform functional testing.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 11 conforming clips.In addition, the device was locked out as intended.The jammed clips may have caused the device to not fire the clips properly and the open handle; however, no conclusion could be reached as to what may have caused the clips jamming.The device was disassembled to verify the condition of the internal components and no anomalies were noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: insert the clip applier through an appropriately-sized trocar.The empty jaws will passively collapse as they are inserted through a 5 mm trocar and reopen when completely through the trocar.Prior to positioning the jaws around the tubular structure or vessel, load a clip into the jaws by partially squeezing the trigger in a smooth continuous motion for approximately one-third of the total firing stroke.Prior to loading a clip in the jaws and firing the instrument: ensure that the jaws are fully open by verifying that the line of demarcation between the jaws and the instrument shaft is past the distal end of the trocar cannula.Prior to positioning the jaws around the tubular structure or vessel, load a clip into the jaws by partially squeezing the trigger in a smooth continuous motion for approximately one-third of the total firing stroke.Position the jaws with the preloaded clip completely around the tubular structure or vessel to be ligated.The structure to be ligated should be positioned against the apex of the clip.Firing the instrument over another clip or instrument can also damage a properly deployed clip, disrupt related vessels and structures, and damage the instrument.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 during an unknown procedure that the clip applier failed.No further information was provided.Unknown as to how the procedure was completed.No patient consequences were reported.

• 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 ; *
• MDR Report Key: 14803016
• MDR Text Key: 298790737
• Report Number: 3005075853-2022-04141
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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: X9416M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1