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

Catalog Number ER320

Device Problems Failure to Fire (2610); Difficult to Open or Close (2921); Firing Problem (4011)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that during a cholecystectomy, force was required to engage the clip.When the handles were fully squeezed shut, the handle became stuck.Force was required to open jaws of device.Another like device was used to complete the procedure.No patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 8/7/2023 d4: batch # x7001v additional information was requested and the following was obtained: "the device was stuck in the cystic duct when it would not open.There was no damage to the tissue.The device was opened when the surgeon used both hands to pry open the handle.The surgeon stated this happened several times recently in other cases, not this case.A second pc was created to cover that statement.I do not have dates or case information from that statement.This info was collected by me, as i was in the case." 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.In addition, the packaging opened was returned along with the instrument.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 and lot number, and no non-conformances were identified.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17477108
• MDR Text Key: 321230429
• Report Number: 3005075853-2023-05559
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2023

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: ER320
• Device Lot Number: 298C79
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1