MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. FLEX 60 ARTICULATING; STAPLE, IMPLANTABLE

Catalog Number EC60A

Device Problems Failure to Cut (2587); Insufficient Information (3190)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 3/14/2024 d4: batch # 575c08 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.Please explain in detail what was the issue with the device.Did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? was there any difficulty opening the device? if yes, how was the device removed from the patient? if yes, did the jaws eventually open? is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) 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 the ec60a device was returned with the handle shroud partially open between the indicator and knob area and with one gst60g reload loaded in the device.The reload was received fully fired with some malformed staples and damage on cartridge deck.The device was tested for functionality in the articulated position with a test reload and achieved its complete firing sequence without any difficulties.The cut line was completed and the staples meet the staple form release criteria.However, the cut was noted to be jagged due to a damaged knife.In addition, a tyvek was received along with the device.The device was disassembled in order to verify the condition of the internal components and no anomalies were noted.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.The event reported was confirmed and it is related to improper use of the device.The damage to the reload is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.It is possible that the damage on the handle shrouds was due to improper handling of the device.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 575c08, and no non-conformances were identified.

Event Description

It was reported that there was an issue when using device on a gastrectomy bypass.No knife after the stapling.Defective anastomosis with risk of tearing of tissues.The sutures were performed by hand with threads, what cause a loss of time.No patient consequences reported.No further information is available.

• Brand Name: FLEX 60 ARTICULATING
• Type of Device: 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, MA ; * ; 3035526892
• MDR Report Key: 18902221
• MDR Text Key: 337634397
• Report Number: 3005075853-2024-02176
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001706
• UDI-Public: 10705036001706
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081146
• 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
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC60A
• Device Lot Number: 635C55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2023
• 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
• Treatment: GST60G