MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; APPLIER, SURGICAL, CLIP

Catalog Number	LX207
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/23/2025.D4: batch#: unk.Additional information was requested and the following was obtained: "how did device not work? as reported the device was getting jammed in the or while using, i.E.After applying the clip, it was not opening by its own, some problem with the recoil mechanism, the surgeon was getting disturbed hence product discarded.Did device jammed (not fire clips)? yes, the device was unable to open after firing the clips, there was a recoil problem reported.Did device not feed clips? the clips were feed manually, but when it was getting jammed after application of clips, applicator not getting opened up by itself to feed another clip, the device was discarded.Did device drop or eject clips? no such problem reported.Did device fire malformed clips? no such problem reported.Did device fire scissored clips? no such problem reported.If other please specify.Is the current patient status known? case was completed, as they has another device to complete the case as mentioned, no such patient adverse event reported 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.) no such problem reported." 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.
Event or Problem Description
It was reported that during an unknown procedure, device getting stuck in between while lodging the clips, it was not opening back on its own.

• Common Device Name: APPLIER, SURGICAL, CLIP
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21901020
• Report Number: 3005075853-2025-02979
• Device Sequence Number: 15652272
• Product Code: GDO
• UDI-Device Identifier: 20705036012891
• UDI-Public: (01)20705036012891(17)401231(10)FQGA14678
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 04/24/2025

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: LX207
• Device Lot Number: FQGA14678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown