MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PNEUMOPERITONEUM NDL; APPARATUS, PNEUMOPERITONEUM, AUTOMATIC

Catalog Number	PN150
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the package received was nonsterile; the entire lot appeared contaminated and every single thing has white particle.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/23/2026.D4: batch # unk.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 lot number, and no non-conformance 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/20/2026.Investigation summary.The product was returned to ees for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that eight (8) pn150 packaging were returned, five (5) with the device inside it's packaging unopened, two (2) with the device inside it's packaging opened and one (1) packaging empty.In addition, the luer lock connector was returned inside a plastic bag.Upon visual inspection of the packaging, a foreign matter was noted to be on it, and it was confirmed to be white flakes from the tyvek.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on how these white flakes get loose from the tyvek.The reported complaint was confirmed.Device history review a manufacturing record evaluation was performed for the finished device lot 824a71 number, and no non-conformances were identified.

• Common Device Name: APPARATUS, PNEUMOPERITONEUM, AUTOMATIC
• 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: 24166777
• Report Number: 3005075853-2026-00732
• Device Sequence Number: 9589867
• Product Code: FDP
• UDI-Device Identifier: 10705036012979
• UDI-Public: (01)10705036012979(17)280229(10)344C39
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: PN150
• Device Lot Number: 344C39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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