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); Failure to Fire (2610); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/08/2022

Event Type  Injury  

Event Description

It was reported that during a laparoscopic cholecystectomy, jamming occurred and the protruded clip damaged the cystic artery.The bleeding occurred and it could not be controlled, so the operation converted to the open procedure.The bleeding amount is unknown.The blood transfusion was not performed.The device was used on the blood vessels.The operation was converted to open procedure to hemostasis and completed the case.The device fed clip into the jaw properly.No further information is available.

Manufacturer Narrative

(b)(4).Batch # unk.Report source is hcp.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.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Video analysis: after analysis of the provided video.When the el5ml device is activated, the jaws are damaged when interacting with another device used in the surgery.The instructions for use do contain the following caution: firing the instrument over another clip or instrument can also damage a properly deployed clip, disrupt related vessels and structures, and damage the instrument.Excessive tissue manipulation with clip in jaws may result in clip dislodgement.Avoid firing the instrument over another clip or instrument.Firing the instrument in this manner may distort or yield the instrument jaws, which can cause the instrument to release the clip prematurely.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information received: from the video, the clip was unformed and the bleeding could not be controlled.The operation was converted to open procedure and it stopped bleeding.The hemostasis method is unknown.The patient is stable.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: were there any issues noticed with the device during surgery? was the clip fully advanced and visualized in the jaws prior to firing? does the surgeon load the clip off of the vessel into the device jaws before applying the device jaws to the vessel and firing? how many clips had been fired prior to the device jamming? what is the current patient status? 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: 8/18/2022 photo analysis: the photo shows a ligamax-5mm endo clip applier device, the picture is not clear to determine the failure mode of the damage jaws.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 revealed that the el5ml device was returned with no apparent damage.In addition, the tyvek was returned along with the instrument.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 5 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 torquing 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.

Manufacturer Narrative

(b)(4).Date sent: 9/22/2022.Additional information was requested and the following was obtained: were there any issues noticed with the device during surgery? the clip was unformed.No further information will be available.Was the clip fully advanced and visualized in the jaws prior to firing? no further information will be available.Does the surgeon load the clip off of the vessel into the device jaws before applying the device jaws to the vessel and firing? no further information will be available.How many clips had been fired prior to the device jamming? no further information will be available.What is the current patient status? the patient is stable.No further information will be available.

• 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: 15094335
• MDR Text Key: 296492374
• Report Number: 3005075853-2022-04827
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: X95236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 07/26/2022; 08/25/2022
• Supplement Dates FDA Received: 08/18/2022; 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention