MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED PLUS COMPACT 45; STAPLE, IMPLANTABLE

Catalog Number	PCEE45A
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/10/2026 d4: batch # 573d31 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: was the firing sequence started but not completed? if yes: did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line? was there any difficulty opening the device jaws? 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 one pcee45a device was returned with the anvil bent upwards and with one gst45t reload loaded in the device.The reload was received partially fired 2/3.Furthermore, the anvil knife slot was noted to be damaged.Upon analysis, the jaws and closure trigger were noted in the close position, the knife was noted to be slightly advanced.The manual override door was noted to be out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequence firings.After further evaluation, the analysis showed the knife wings were broken off.No functional test was performed due to the condition of the device.The partially fired is consistent with an incomplete or interrupted cycle.It is possible that the device was clamped over an excess of tissue causing the anvil to bend and for the firing stroke and the staple form to be incomplete.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness or tissue that cannot compress to the indicated range for the selected reload.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.The damage to the knife is consistent with the device being clamped over an excess of tissue.If the firing continues the knife will remain inside the guide, and as the knife is attempting to pull the anvil towards the reload to form the staples it will result in the damage observed on the knife.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 573d31, 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
Vats lobectomy device locked on lung tissue and after attempts to remove using both the reverse button and the manual override, jaws would still not open.Device had to be manually opened using another instrument.An alternative device was opened and used to complete the procedure.No adverse effects.

• Brand Name: POWERED PLUS COMPACT 45
• Common Device Name: STAPLE, IMPLANTABLE
• 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 00969 ; * 00969 ; 3035526892
• MDR Report Key: 24304703
• Report Number: 3005075853-2026-01197
• Device Sequence Number: 5240384
• Product Code: GDW
• UDI-Device Identifier: 10705036015338
• UDI-Public: (01)10705036015338(10)573D31(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163454
• 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): 02/10/2026

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: PCEE45A
• Device Lot Number: 573D31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2025
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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