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 05/14/2022

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic sigmoidectomy, the way a clip was fed into the jaws felt unusual.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Batch # unk.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 apparent damage.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, one clip partially formed was feed due to an anti-backup failure and then it fed and formed 9 conforming clips as expected.In addition, the device lockout as intended.In order to evaluate the device¿s internal components the instrument was disassembled.Upon disassembling of the device, the ratchet pawl was found damaged causing the anti-backup failure.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon¿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: 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.Additional information was requested, and the following was obtained: please clarify how the ¿the way a clip was fed into the jaws felt unusual¿.Did device was difficult to fire? =>no.Did device make any noise? =>no.Did device feed clips sideways?=>no.Did device not fire clips (jammed)?=>no.Did device fire malformed clips? =>no.Did device fire scissored clips? =>no.Did device drop or eject clips? =>no.If other, please specify 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 ; *
• MDR Report Key: 14840900
• MDR Text Key: 300350907
• Report Number: 3005075853-2022-04210
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2022

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
• Device Lot Number: X9455D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1