MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*PPH PROCEDURE SET; STAPLE, IMPLANTABLE

Catalog Number	PPH03
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, they were able to fire the device but with incomplete donut mucosa is not connecting after the firing.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent 11/13/2025.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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 12/4/2025.D4 batch #442d40.Investigation summary: the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample determined that the pph03 device arrived with no apparent damage along with the accessories.The breakaway washer uncut and indented and there were only 3 partially formed staples in the pockets.The device was reloaded with staples and tested for functionality with a test washer; the device formed all the staples, as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.The condition of the washer indicates that the device had not been fired through a full firing stroke or possibly that the orange indicator was not fully into the safe green firing range.Before firing the device the orange indicator should be fully within the green range of the gap setting scale and the safety should not be released prior to firing.Also, if the firing sequence is not fully completed (the firing handle reaches its stopping point, and the firing trigger is parallel to the instrument handle) staples could be partially deployed without cutting the washer.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 442d40, and no non-conformances related to the reported complaint condition were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• 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: 23543479
• Report Number: 3005075853-2025-08745
• Device Sequence Number: 9284346
• Product Code: GDW
• UDI-Device Identifier: 10705036013006
• UDI-Public: (01)10705036013006(17)300331(10)559D25(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: PPH03
• Device Lot Number: 559D25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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