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

Catalog Number	B12XT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 01/07/25.D4: batch #unk.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 device lock-out (no staples deployed and no cut line started)? or, did the device start to deploy staples and cut but could not be completed (partially fire)? or, did the device fully fire and stop during the automatic knife return? was there any difficulty opening the device? if yes, how was the device removed from the patient? if yes, did the jaws eventually open? could you please specify how the trocar was damaged, was the sleeve damaged? was the housing damaged? was there any insufflation issue? was there any seal damaged? any visible broken part? 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 b12xt with lot number 539c42; and no non-conformances were identified.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 a lobectomy procedure, it was observed that in the course of a procedure using the psee60a, an error occurred in the process of firing.When surgeon pulled back the safety lock and fired the trigger, the blade was suddenly stopped in the middle of cartridge.It occurred two more times.As an emergency measure, the surgeon backed off the blade and detached it from the tissue.It was further reported that the trocar had been bent when it was inserted into the body.There were no adverse consequences to the patient nor surgical delay reported.Additional information requested.
Additional Manufacturer Narrative
(b)(4).Date sent 8/5/2025.D4 batch #a9dc6u.Investigation summary- the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the b12xt device was returned outside it's package opened with no apparent damage.The device was visually inspected and no damaged found on the sleeve.The device was fully functional according to the manufacturing requirements.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without any damaged.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch a9dc6u number, and no non-conformances were identified.

• Brand Name: ENDOPATH XCEL BLADELESS 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 00969 ; 3035526892
• MDR Report Key: 21095289
• Report Number: 3005075853-2025-00161
• Device Sequence Number: 9161553
• Product Code: GCJ
• UDI-Device Identifier: 10705036001195
• UDI-Public: (01)10705036001195(10)539C42(17)280630
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/05/2025

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: B12XT
• Device Lot Number: 539C42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2024
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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