MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 440MM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PLEE60A

Device Problems Mechanical Problem (1384); Failure to Fire (2610); Mechanical Jam (2983); Firing Problem (4011)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that during an unk procedure, 1 hour into the case, stapler was setup as per odp as instructed by hcp.Scrub nurse then passed the stapler to hcp.Hcp inserted the stapler into the patient and clamped onto the patient's stomach ready for the first firing.After waiting for 15s pre-compression, hcp pushed back the red safety and pressed the black firing trigger.Nothing happened, the stapler did not fire.Thinking it was a reload loading issue, hcp instructed the scrub nurse to change a new reload.Old reload was removed and new reload inserted as per odp.When hcp tried to fire the stapler again the second time with the new reload, nothing happened again.The stapler could not fire the second time.This time, hcp removed the stapler from the patient and tried to fire the stapler outside of the patient to figure out what went wrong.The stapler could fire across but the engine sounded weak and the knife blade move forward really slowly.When the knife blade reached the end of the jaw, the knife blade could not return to the housing and hcp has to engaged the 'reverse button'.The 'reverse button' managed to pull the knife blade back to the stapler housing and hcp could open the jaw of the stapler.Upon inspecting, hcp found out that even though the knife blade has moved forward and back on the jaw, no staple was being pushed out.Hcp also tried to remove the battery to inspect if it could be the battery issue, but the battery was stuck and he is unable to remove the battery.New stapler and reload were eventually opened to continue the surgery.No patient consequences were reported.

Manufacturer Narrative

(b)(4) date sent: 11/21/2023 d4: batch # unk.Device evaluation anticipated, but not yet begun.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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: 12/20/2023 d4: batch # 455c73.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 plee60a device was returned with no apparent damage and with two gst60g reloads present.The reloads (b & c) were received unfired.The device was tested for functionality in the straight position with returned reloads (b & c) 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.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: for the battery pack insertion or removal, difficult to fire - firing speed, and would not fire, 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.For the would not staple, tissue thickness should be carefully evaluated before firing any stapler.Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.When positioning the stapler on the application site, ensure that no obstructions such as clips, stents, guide wires, etc.Are within the instrument jaws.Would not reverse knife automatic, tissue thickness should be carefully evaluated before firing any stapler.Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.When positioning the stapler on the application site, ensure that no obstructions such as clips, stents, guide wires, etc.Are within the instrument jaws.The event described could not be confirmed as the device performed without any difficulties noted.Once the device completed the firing sequence the knife returned home as intended.The knife reverse button worked properly during testing.A manufacturing record evaluation was performed for the finished device batch number 455c73, and no non-conformances were identified.

• Brand Name: POWERED 60 ECHELON +, 440MM SHAFT
• 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 ; PR ; 3035526892
• MDR Report Key: 18186522
• MDR Text Key: 328944176
• Report Number: 3005075853-2023-08661
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014614
• UDI-Public: 10705036014614
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLEE60A
• Device Lot Number: A9D678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1