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	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).B3: unknown; captured as awareness date.Date sent 9/11/2025.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that h12lp device was returned inside it's original packaging unopened.Upon visual inspection, it was observed that the pouch from the packaging was damaged; it was noted to have a hole in the pouch, the hole was noted to be from the outside in.The sterility was compromised.The event reported was confirmed and it is related to improper use of the device.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot 160d06 number, and no non-conformances were identified.Additional information was requested, and the following was obtained: was the integrity of the sterilized product compromised? unk.
Event or Problem Description
It was reported that during an unknown procedure, there was a hole in the package before took out the contents, so it could not be used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 23025337
• Report Number: 3005075853-2025-07219
• Device Sequence Number: 9455245
• Product Code: GCJ
• UDI-Device Identifier: 10705036002017
• UDI-Public: (01)10705036002017(17)290531(10)160D06
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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: 160D06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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