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

Catalog Number PSEE45A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

It was reported from the customer that a screw fell out of the device after it was fired.No patient harm.

Manufacturer Narrative

(b)(4).Date sent: 1/11/2024.D4: batch # 646c48.A manufacturing record evaluation was performed for the finished psee45a, with lot/batch number a9e239, 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.

Manufacturer Narrative

(b)(4).Date sent: 2/6/2024.D4: batch # 646c48.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 psee45a device was returned with no apparent damage 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.The device was disassembled to verify the integrity of the internal components and no abnormalities were found.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 646c48, and no non-conformances were identified.

• Brand Name: POWERED PLUS STANDARD 45
• Type of Device: 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18495268
• MDR Text Key: 333197012
• Report Number: 3005075853-2024-00322
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015352
• UDI-Public: 10705036015352
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PSEE45A
• Device Lot Number: A9E239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1