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

Catalog Number	H12LP
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 10/22/2024.D4: batch # unk.Additional information was requested and the following was obtained: "please clarify when issue was identified (pre-op/intra-op) -intraop end of the case was there physical damage to the trocar? please specify part of trocar.-the black tab at suture ring of the hassan "toilet seat" broke off.Was it separated from the device? did any pieces fall into the patient? no.If yes, were they retrieved? will all pieces be returned with the device? yes.If no, were they discarded".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 proceudre, trocar - piece broke off , uncertain when it came off.No patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/9/2025.Investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that only the sleeve from the h12lp device was received with one suture tie post broken.The suture tie post was returned inside a plastic bag.In addition, the tyvek was returned along with the instrument.No conclusion could be reached as to what may have caused the reported incident.One possible cause for the damage found on the suture tie post may be excessive force applied after device is sutured down.A manufacturing record evaluation was performed for the finished device lot 924c03 number, and no non-conformances were identified.

• Brand Name: ENDOPATH XCEL BLUNT TIP TROCAR
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20506813
• Report Number: 3005075853-2024-07941
• Device Sequence Number: 20908905
• Product Code: GCJ
• UDI-Device Identifier: 10705036002017
• UDI-Public: (01)10705036002017(17)290228(10)924C03
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/09/2025

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: H12LP
• Device Lot Number: 924C03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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