MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	D11LT
Medical Device Problem Codes	Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	12/03/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Date sent: 12/31/2024.D4: batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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: "¿what was the procedure type? ¿what is the patients bmi? ¿what is the surgeons specialty? ¿what is the surgeons experience with this device? ¿did this occur during the first trocar puncture of the procedure? if not what puncture? ¿was insufflation achieved? ¿was the trocar placed blindly or was there visualization from another port? ¿was a skin incision created prior to trocar entry? ¿what was the patient positioning at the time of entry? ¿does the surgeon believe that the alleged device deficiency caused or contributed to the event? if so, please describe." "is the surgeon interested in speaking with ethicon medical and engineering to discuss the event? please provide 3 thirty-minute windows of time (eastern us time zone) that the surgeon would be available for a call.The ethicon team will pick the time that the most members can participate and schedule." 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, severe event, patient death, with vascular trauma to the left iliac during the first puncture with device.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/27/2025.Additional information was requested and the following was obtained: "procedure: programmed hernia surgery.It seems that the surgeon had a vascular trauma punctured with the trocar the left iliac (not clear if artery or vein).The surgeon didn¿t discuss the case with us or give more information." an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: XCEL DILATING TIP TROCAR 11MM
• 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: 21048030
• Report Number: 3005075853-2024-09909
• Device Sequence Number: 16963866
• Product Code: GCJ
• UDI-Device Identifier: 10705036001560
• UDI-Public: (01)10705036001560(17)290531(10)139D80
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/27/2025

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: D11LT
• Device Lot Number: 139D80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown