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

Catalog Number	PLEE45A
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, during the first firing the motor paused for an unusually long time and then restarted again.The device was then reloaded and when the surgeon went to fire the device, but it would not fire and potentially locked out.The scrub thinks the surgeon tried the reverse knife button, but this didn¿t work and then they used the manual override and got a new echelon to complete the procedure.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/29/2024 exact event date unk, entered 1/1/2024 as only the year was provided.Batch # 467c71.Investigation summary the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one plee45a device was returned with no apparent damage and with a gst45b reload loaded on the device.The reload was received partially fired 1/3.The manual override door 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 subsequent firings.The bailout system was reset and then, the returned device and reload were tested for functionality in the straight position by resetting and reloading it into the device.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples meet the staple form release criteria.Once the device completed the firing sequence the knife returned home as intended.The knife reverse button worked properly during testing.The device opened and closed without any difficulties noted.The partially fired is consistent with an incomplete or interrupted cycle.Please reference the instruction for use for more information.Device history review a manufacturing record evaluation was performed for the finished device batch number 467c71, and no non-conformances were identified.

• Brand Name: POWERED PLUS LONG 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: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 19006325
• Report Number: 3005075853-2024-02495
• Device Sequence Number: 9420502
• Product Code: GDW
• UDI-Device Identifier: 10705036015345
• UDI-Public: 10705036015345
• 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): 03/29/2024

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 Expiration Date: 05/30/2026
• Device Catalogue Number: PLEE45A
• Device Lot Number: 467C71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown