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

Model Number EL5ML

Device Problems Mechanical Problem (1384); Failure to Fire (2610); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) batch # v94r26.(b)(4).Investigation summary the product was returned for evaluation.In addition, a tyvek was received along with the device.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined the el5ml device was returned with the orange indicator that appears on the top of the handle and no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, it was noted that the clips did not fully advance into the jaw.The device was disassembled in order to evaluate the condition of the internal components and no anomalies were noted.In addition, fourteen clips were found inside clip track.No conclusion could be reached regarding what may have caused the condition of the indicator and may have caused the feeding incident.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." 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 inguinal hernia repair, there were no clips in the device and the indicator was already orange when removing the device from the packaging.The item couldn't be used.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: 12755662
• MDR Text Key: 281765507
• Report Number: 3005075853-2021-06667
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2021
• 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: V94R26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1