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

Model Number EL5ML

Device Problems Failure to Form Staple (2579); Insufficient Information (3190)

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

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) batch #v95g6w.Investigation summary : the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined that the el5ml device was returned with no apparent damage.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 eight conforming clips.The event described could not be confirmed as the device performed without any difficulties noted.Although no conclusion could be reached regarding the cause of the reported event, the instructions for use do 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 batch number, and no non-conformances were identified.

Event Description

It was reported by the sales rep that during a laparoscopic cholecystectomy the device clips were scissoring.The term ¿scissoring¿ is commonly used to describe malformed clips.After being fired, the legs of the clip did not align parallel like they are supposed to, but instead they were askew and resembled an open pair of scissors.They did not cut the tissue but they also failed to ligate the tissue.Another device was used to complete the case with no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2021.D4: lot/batch number is v95g6w.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.Additional information provided: sometimes they (clips) can be very difficult to remove.

• 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
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12995545
• MDR Text Key: 286935533
• Report Number: 3005075853-2021-07681
• 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,Followup
• Report Date: 12/14/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1