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)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

It was reported that during a robot assisted rectum procedure, the trigger was stiff at 3rd firing.The device was inserted from the assisted port.The device locked out when the trigger was grasped outside patient.Manual override lever was used, but the jaws did not open.Hem-o-lok was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 8/29/2023.D4: batch # a9c22x.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 returned with the jaws closed and with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the trigger could not be activated due to be jammed.The device was disassembled to evaluate the condition of the internal components and the trigger was found bent, not allowing the clips to fed into the jaws.In addition, 1 conforming clip that was in the jaws and 16 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.

Manufacturer Narrative

(b)(4).Date sent: 2/14/2024.Additional analysis was completed on the device: "the cracks and crazing in the twist area of the trigger indicate a mechanical failure.The cracks and crazing in the slot region of the trigger indicate mechanical damage.There is crazing and damage on other parts of the trigger.".

• 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: 17642155
• MDR Text Key: 322175071
• Report Number: 3005075853-2023-06202
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K864102
• 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: 02/14/2024

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: 278C10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1