MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LAPRA-TY* APPLIER - 33CM; APPLIER, SURGICAL, CLIP

Catalog Number	KA200
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery, the devices could not perform ligation, and they would open up.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2025.D4: batch#: unk.Additional information was requested and the following was obtained: "how did device not work? unk.Did device jammed (not fire clips)? unk.Did device not feed clips? unk.Did device drop or eject clips? unk.Did device sideways feed clips? unk.Did device fire malformed clips? unk.Did device fire scissored clips? unk.Did the device eventually open? unk.If other please specify." 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.
Additional Manufacturer Narrative
(b)(4).Date sent 5/6/2025.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent 5/29/2025.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the ka200 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained, and deployed 6 clips as intended over the suture.The instrument was fully functional and conforming.The device opened as expected.The event described could not be confirmed as the device and clips performed without any difficulties noted.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.Although no conclusion could be reached on the cause of the reported event, it should be noted that the applier should be grasp by the handle and insert the jaws of the instrument into the individual cartridge slot.Ensure the tips of the applier are perpendicular to the surface of the cartridge.Insert the applier until it stops.Do not force the applier.It should enter and withdraw from the cartridge smoothly.Withdraw the applier from the cartridge.The clip will be securely held in the applier jaws.Place a suture clip approximately 5 mm from the cut end of the suture.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• Common Device Name: APPLIER, SURGICAL, CLIP
• 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21882945
• Report Number: 3005075853-2025-02852
• Device Sequence Number: 7865357
• Product Code: GDO
• UDI-Device Identifier: 20705036012648
• UDI-Public: 20705036012648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: KA200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 05/05/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/06/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown