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

Catalog Number	B12SRT
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/23/2025.D4: batch # unk.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 when opened the package of the trocar, the outer seal came off and the device fell to the floor, so it became unclean.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/8/2025.
Additional Manufacturer Narrative
(b)(4).Date sent 5/9/2025.D4 batch #c9dz9p.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that b12srt device was returned outside it's package opened and with no apparent damage.In addition, universal seal was returned unlatch from the sleeve.In an attempt to replicate the reported incident, the device was functionally tested to detect any reducer attachment removal issues.Upon evaluation of the device had the universal seal latch onto the sleeve assembly.In addition, the obturator latch onto the universal seal as well.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 performed without any difficulties noted.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 c9dz9p 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21894699
• Report Number: 3005075853-2025-02940
• Device Sequence Number: 3405571
• Product Code: GCJ
• UDI-Device Identifier: 10705036001188
• UDI-Public: (01)10705036001188(17)290430(10)982C41
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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: B12SRT
• Device Lot Number: 982C41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 05/08/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/08/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown