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

Catalog Number	PLEE45A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, the surgeon attempted to fire and it partially went and stopped.Used the reverse knife blade and was able to open and remove from patient.Opened new stapler to complete firing of the gj anastomosis.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/5/2024.D4: batch # 890c64.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 with a tyvek and with no reload present.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: ensure battery pack is fully inserted into the device.An audible click will be heard when the battery pack is fully inserted (the instrument must be used within 12 hours of inserting the battery pack, the battery pack contains a built-in battery drain).Insert the reload by sliding it against the bottom of the cartridge jaw until the cartridge alignment tab stops in the reload alignment slot.Snap the reload securely in place.Remove the staple retaining cap and discard.Close the jaws of the instrument by squeezing the closing trigger until it locks in place.An audible click indicates that the closing trigger and the jaws are locked.When the jaws of the instrument are closed, the red firing trigger lock and firing trigger are exposed.Pull back the red firing-trigger lock to enable the firing trigger to be pulled.Fire the instrument by pulling the firing trigger; the motor will activate audibly.Continue to depress the trigger until the motor stops.To complete the firing sequence, release the firing trigger to activate the motor and automatically return the knife to home position where the motor will stop.In this position, the instrument is locked out until the jaws are opened and re-closed.The event described could not be confirmed as the device performed without any difficulties noted.Device history review: a manufacturing record evaluation was performed for the finished device batch number 890c64, 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 ; * ; 3035526892
• MDR Report Key: 19683280
• Report Number: 3005075853-2024-04914
• Device Sequence Number: 6917799
• Product Code: GDW
• UDI-Device Identifier: 10705036015345
• UDI-Public: 10705036015345
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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 Catalogue Number: PLEE45A
• Device Lot Number: C9DR75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown