MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	D12LT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint: (b)(4).Date sent: 1/12/2026.D4: batch # unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.1.Any visible broken part? 2.What part broke of the device broke? 3.Could you please specify how the device was damaged? 4.Did the damage occur right out of the packaging or in the operative field? 5.Did any pieces fall into the patient? 6.If yes, were they retrieved? 7.Will all pieces be returned with the device? 8.If no, were they discarded? 9.Was there a patient consequence? 10.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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 unk procedure, the plastic defect of the trocar.No further details were provided.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent 2/24/2026.D4 batch #518d10.Photo analysis: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: photos a xcel dilating tip trocar 12mm with a plastic edge in the universal area, the sample can be observed outside its packaging.No conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.A manufacturing record evaluation was performed for the finished device 518d10_d12lt batch number, and no non-conformances were identified.

• Brand Name: XCEL DILATING TIP TROCAR 12MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 24044937
• Report Number: 3005075853-2026-00382
• Device Sequence Number: 9010685
• Product Code: GCJ
• UDI-Device Identifier: 10705036001577
• UDI-Public: (01)10705036001577(17)300228(10)518D10
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K032676
• 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,Followup
• Report Date (Section B): 02/24/2026

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: D12LT
• Device Lot Number: 518D10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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
• Patient Sex: Unknown