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 Advance (2524); Failure to Form Staple (2579); Failure to Fire (2610); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during a laparoscopic cholecystectomy, jamming occurred, and the clip was not formed on the ¿cystic artery.The clip was unformed.The jaws were broken.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

Pc-000795(b)(4).337 date sent: 12/11/2020 d4: batch # u94z0d f10 and h6 component code: others (g07).Investigation summary the analysis results found that the el5ml device was returned with no apparent damage and one clip loaded in the jaws was noted.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 2 conforming clips.The event described could not be confirmed as the device performed without any difficulties noted.Although there is no direct evidence of use error, the instructions for use do contain the following: "caution: 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.Complete the firing cycle by squeezing the trigger until it stops against the handle to completely form the clip on the targeted structure or vessel.After firing, fully release the trigger.As additional instruction for use, do not excessively twist or torque the instrument jaws when positioning or firing the instrument on a tubular structure or vessel.Excessive twisting or torqueing may result in clip malformation." it should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be 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.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10837390
• MDR Text Key: 216218226
• Report Number: 3005075853-2020-05986
• 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
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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: U94Z0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 11/18/2020
• Patient Sequence Number: 1