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 12/01/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the device could not be fired properly at 1st firing outside the patient, and the jaws did not open.The jaw closes even the clip could not be fed into the jaw properly.Additional suture was performed to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 12/28/2023 b3: unknown, assumed first day of month that complaint was reported d4: batch # unk additional information was requested and the following was obtained: "1.Please provide more details about statement: ¿the device could not be fired properly at 1st firing¿ did device not feed clips?=>currently, unknown.Did device feed clips sideways? =>currently, unknown.Did device not fire clips (jammed)? =>no.Did device fire malformed clips?=>no, device could not be fired.Did device fire scissored clips? =>no, device could not be fired.Did device drop or eject clips?=>no, device could not be fired.If other, please specify 2.Please clarify how ¿the clip could not be fed into the jaw properly¿ did device not feed clips?=>currently, unknown.Did device feed clips sideways?=>currently, unknown.Did device not fire clips (jammed)?=>no, device could not be fired.Did device fire malformed clips? =>no, device could not be fired.Did device fire scissored clips? =>no, device could not be fired.Did device drop or eject clips? =>no, device could not be fired.If other, please specify 3.Please clarify how ¿and the jaws did not open¿ were the device jaws eventually opened? =>currently, unknown.Was the device on tissue when it would not open? =>no.If yes, how was the device removed from the tissue? =>n/a." 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: 1/31/2024.Batch # a9c858 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, 20 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18409800
• MDR Text Key: 331508069
• Report Number: 3005075853-2023-09931
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: BATCH:A9C858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1