MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Model Number ER320

Device Problems Difficult to Open or Close (2921); Firing Problem (4011)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, when applying the er320 clips, the applicator seemed harder than usual.They applied the clips a couple of times and on the third application, the applicator did not open.It was impossible to pull the applicator out of the artery.They had to apply hemolocks on both sides of the er320 clip application site, sectioning the artery to be able to remove the er320 device.The artery was completely severed, as they could not get the er320 device out any other way.

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "in fact, there was not any abnormal bleeding at all.As the problem was related to the fact it was not posible to open the clip applier to continue the surgery.An artery was being completely blocked in order to section it safely, as the surgeons planned to do in their procedure.Two hem-olock had to be applyed on both sides of the clip applier which was not openning, to be able to section the part of the artery trapped by the failing device so the surgeons could cut the piece of artery stuck in the device, to finally take the device out of the trocar and continue the rest of the surgical procedure.Therefore, the answer to the questions formulated is this: how much bleeding occurred? none how was the bleeding controlled? it was not requiered were any blood products given? no if yes, how much blood did the patient require? none did the patient require any different type of post op care due to bleeding? no what is current patient status? recovered" a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.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: 2/15/2023.

Manufacturer Narrative

(b)(4).Date sent: 1/11/2023.This is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows a device in its packaging in the open position.Based on the photo review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.

Manufacturer Narrative

(b)(4).Date sent: 4/11/2023.D4: batch # v96d0p.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 er320 device was received with the trigger broken.The device was disassembled to evaluate the condition of the internal components and the trigger was found broken, not allowing the clips to fed into the jaws.In addition, 18 clips were found remaining inside the clip track.The damaged on the device could be that the internal ribs were being gauged by the feeder link, causing the trigger to experienced additional force that could interfere with the firing of the device.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 number, and no non-conformances were identified.

• 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: 16008220
• MDR Text Key: 308112640
• Report Number: 3005075853-2022-08775
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K864102
• 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,Followup
• Report Date: 04/11/2023

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 Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: 598A77
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 12/20/2022; 02/15/2023; 04/05/2023
• Supplement Dates FDA Received: 01/11/2023; 02/15/2023; 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1