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

Catalog Number	LT300
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 8/14/2025.D4 batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: did the patient receive their radiotherapy? was the post operative care of the patient altered in any way as a result of the clips discharging? was there any medical or surgical intervention required to address the discharged clips from the incision? 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 and unknown procedure, a multiple clip applier and clips were used, in which 5 clips were left in the incision as a marker for postoperative radiotherapy.After the operation, the metal foreign body was repeatedly discharged from the incision, and 4 titanium clips have been discharged so far.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/26/2025.Additional information was requested, and the following was obtained: did the patient receive their radiotherapy? -unknown.Was the post operative care of the patient altered in any way as a result of the clips discharging? -unknown.Was there any medical or surgical intervention required to address the discharged clips from the incision? -unknown.

• Common Device Name: 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22803470
• Report Number: 3005075853-2025-06443
• Device Sequence Number: 21033986
• Product Code: FZP
• UDI-Device Identifier: 10705036012825
• UDI-Public: (01)10705036012825(17)290131(10)863C51
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: LT300
• Device Lot Number: 863C51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown