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

Catalog Number PLEE60A

Device Problems Failure to Cut (2587); Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Firing Problem (4011)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that during an unk procedure, initially the stapler did not trigger/fire, but after several attempts with a green magazine there was a cracking noise in the instrument.The stapler triggered, but without cutting - it was only stapled.The posterior wall of the stomach was torn.The patient be treated surgically.

Manufacturer Narrative

(b)(4).Date sent: 1/8/2024.B3: exact event date unk, entered 1/1/2023 as only the year was provided.D4: batch # unk attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished plee60a, with lot/batch number a9cz2c, and no non-conformances were identified.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.What is meant by "after several attempts"? for any additional attempts did they change any of the cartridges? what was the surgical procedure? what firing number of the device did the event occur on? what is meant by the "the patient be treated surgically."? was this surgical treatment in the initial procedure or additional procedure? please clarify "initially the stapler did not trigger, /fire"? please clarify what is meant by " stapler did not trigger, /fire"? are photos available of the cartridge used? 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: 2/21/2024.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

(b)(4).Date sent: 2/22/2024.Additional information was requested and the following was obtained: what is meant by "after several attempts"? after several attempts to fire for any additional attempts did they change any of the cartridges? yes what was the surgical procedure? sleeve what firing number of the device did the event occur on? unk what is meant by the "the patient be treated surgically."? the final row of staples had to be surgically treated in another way - sutured over was this surgical treatment in the initial procedure or additional procedure? initial please clarify "initially the stapler did not trigger, /fire"? during the first attempt they already has problems to release the magazine please clarify what is meant by " stapler did not trigger, /fire"? ? did not fire are photos available of the cartridge used? no.

Manufacturer Narrative

(b)(4).Date sent: 3/8/2024.D4: batch # 403c00.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 eight gst60g reloads present.The reloads were received sterile.The device was tested for functionality in the straight position with a returned reload and achieved its complete firing sequence.However, the staples were partially formed.After further evaluation, the analysis showed the knife wings were broken off.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.Please reference the instruction for use for more information.Device history review: a manufacturing record evaluation was performed for the finished device batch number 403c00, 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: 18468824
• MDR Text Key: 332377945
• Report Number: 3005075853-2024-00172
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014614
• UDI-Public: 10705036014614
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLEE60A
• Device Lot Number: A9CZ2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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
• Patient Outcome(s): Required Intervention