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

Catalog Number EL5ML

Device Problems Mechanical Problem (1384); Failure to Form Staple (2579); Mechanical Jam (2983); Mechanics Altered (2984); No Apparent Adverse Event (3189)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 11/10/2023.D4: batch # unk.Additional information was requested and the following was obtained: "there are no particular problems with the patient's condition and the discharge schedule has been decided.Since the ileocecal resection was performed, the event occurred near the ileocolic artery.The amount of bleeding is unknown.The surgeon immediately applied pressure to stop the bleeding, so there was no serious injury.There was no change in the surgical method due to this bleeding.According to the doctor in charge, there was no problem with the usage, and they do not know why it did not form.The second shot misfired, so the surgeon made sure it was loaded and then clipped it.The blood vessel was trapped, but as soon as he released the trigger, the clip came out in a v-shape.He was confused because it happened at the same time as the clipping, but he thinks that for some reason the next clip was coming out at the same time." 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.

Event Description

It was reported that during a laparoscopic colectomy, the clip could not be fed into the jaw at 2nd firing.The clip unformed in u-shape at 7th firing.At that time, the blood vessel was damaged, and the bleeding occurred.The bleeding stopped.The device was used on the ileum.Another device was used to complete the case.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 12/8/2023.D4: batch # a9cw9p.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 received with no damage to the external components.In addition, one(1) malformed clip was returned along with the instrument.Upon cycling, the instrument was noted to be empty and locked out.The instrument is designed to lockout after all the clips have been fired; therefore a potential cause for the customer reported experience is the firing of all of the clips, as a result, the instrument could no longer be fire due to the activation of the lockout mechanism.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.The instrument has an orange indicator that appears on the top of the handle as a reference for the user as to the number of clips remaining.Although no conclusion could be reached on the cause of the reported event as the device was returned empty, the instructions for use do contain the following caution: when the 13th clip is fired, an orange bar will begin to appear in the indicator window on top of the device handle.The orange bar fills the indicator window when the final clip is fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18112138
• MDR Text Key: 327888891
• Report Number: 3005075853-2023-08384
• 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: 12/08/2023

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 Catalogue Number: EL5ML
• Device Lot Number: A9CW9P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1