MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number	LT200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/20/2025.D4: batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "could you please clarify what is meant per event description "the clip is mounted at an angle"? was the handle broken? were the jaws damaged? was the device difficult to fire? difficult to open? did the device fired any malformed clips? did the device would not fire? if other please specify is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.)" investigation summary: the product was returned to ethicon evaluation.Visual inspection was conducted on the returned cartridge.Visual analysis of the returned sample revealed that the lt200 cartridge was received empty with the base detached from the body.In addition, 3 clips were returned malformed and one clip returned unformed.No functional test was performed due to the condition of the clips and cartridge.The condition of reload is related to improper use of the cartridge.According to the separated cartridge, it is recommended to insert the clip cartridge into the loading base.Grasp the applier in the box lock area using pencil grip technique.Insert the jaws of the instrument into the individual cartridge slot, making sure 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.No conclusion could be reach on what caused the condition of the returned malformed clips.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device lot number 410c54, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, the tip doesn't screw on tightly, so the clip is mounted at an angle.No patient consequences reported.

• Common Device Name: 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: 21652170
• Report Number: 3005075853-2025-02048
• Device Sequence Number: 20716801
• Product Code: FZP
• UDI-Device Identifier: 10705036012801
• UDI-Public: (01)10705036012801(17)280430(10)410C54
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: LT200
• Device Lot Number: 410C54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown