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); No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic sigmoidectomy, the root of inferior mesenteric artery was clipped for twice, but the clip did not close properly, and the bleeding occurred from the cut end.The surgeon held the cut end with the forceps and clipped with another device.Another device was used to complete the case.No further information is available.

Manufacturer Narrative

(b)(4).Attempts have been 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.No lot or batch number was provided therefore a device history could not be done.Additional information provided: the bleeding once occurred from the cut end of the root on the ima, but it was held by the forceps and clipped, so no blood transfusion was performed.The surgeon commented that the device was fully grasped, and the patient was being careful to not put the pressure on the root.The patient is stable.The device was replaced to er420 and double clipped the root of the ima.When checking the video, it was found that the 1st clip was loose.The 2nd clipping was clipped properly.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.

Manufacturer Narrative

(b)(4).Date sent: 09/22/2022.D4: batch # x94t5j.Investigation summary: the product was returned 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 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 10 conforming clips.Upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended.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 do contain the following caution: 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.Do not insert the clip applier through a trocar if a clip is present in the jaws.This may result in clip malformation, dislodged clips, or damage to the instrument.If a clip is present in the jaws, fully squeeze the trigger against the handle, then fully release the trigger to release the clip from the jaws before inserting the device through the trocar.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device lot/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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15258732
• MDR Text Key: 305250374
• Report Number: 3005075853-2022-05444
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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: X94T5J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1