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

Catalog Number EC60A

Device Problems Mechanical Problem (1384); Failure to Fire (2610); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2023

Event Type  Injury  

Event Description

It was reported that during an unk procedure, the surgeon was resecting below the caecum above the appendix however the surgeon was unable to open the gun.They tried to use the jaw release/opening button at the rear of the device however this did not work.They continued to try using this button however the button then broke.They then tried to push down the red knife reset button and pull back the grey firing trigger and try to use the opening button again however this still did not open the device.The surgeon then had to extract the gun and specimen using another method.

Manufacturer Narrative

(b)(4).Date sent: 12/27/2023.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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information was requested and the following was obtained: which colour reload was loaded into the device? blue was this the first time during the case the stapler was used/fired? yes what procedure was being performed? limited care already resection what/where was the stapler being used to resect? caecum, at the base of appendix had the staples been fired before you were unable to open the jaws or were you trying to reposition/open and then regrasp the tissue before firing the staples? they had been fired if the staples had been fired, had the firing stroke/trigger been fully depressed 4 times? yes please could you explain how the stapler was removed from the tissue/patient and how this changed the procedure? i tried to hammer the button open, with no joy.I then had to physically break the instrument to get it off the caecum.The red button was of no use.Please clarify if there were any patient consequences? yes, laparotomy.Awaiting recovery , but it¿s still early.Los has greatly increased.Please clarify if there is any change in the post-operative care of the patient as a result of the event? yes, lots, as a result of laparotomy.In addition to this the surgeon has informed the staples only seemed to be half fired.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: (b)(6) 2024 d4: batch # (b)(4).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 received for analysis with release button broken off no returned and with the closing trigger and anvil in the closed position.Also, an unknown trocar was returned inserted in the shaft of the device.A gst60b cartridge was loaded on the device.The cartridge was received partially fired 2/3 with the cartridge deck damaged.The device was disassembled in order to open the jaws.The jaws were manually open and the device was tested for functionality in the articulated 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.One possible scenario for the described event is due to applying a large prying force on the closure trigger handle in the opening direction.This can then result in damage to the release button if the applied load is high enough.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.Please reference the instruction for use for more information.Although no conclusion could be reach on the cause of the reported event of "manual switch issue", the instructions for use do contain the following caution: if the jaws do not automatically open after the anvil release button is pressed, first ensure that the knife is in the retracted position by verifying that the stroke count indicator displays ¿0¿ and knife direction indicator points towards the proximal side of the instrument, or that the knife blade indicator is in the home position.If the stroke count indicator or knife blade indicator is not in the home position, push the red manual knife reverse switch downward to reverse the knife motion and squeeze the firing trigger, completely until it rests on the closing trigger.Press the anvil release button.If the jaws do not open at this point, then gently pull the closing trigger, upward (away from the handle) until both firing and closing triggers return to their original positions.Attempting to force the trigger to complete the firing stroke with too much tissue between the jaws, or with dense/thick tissue between the jaws, may result in increased forced to fire or instrument failure.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review a manufacturing record evaluation was performed for the finished device batch number 446c09, and no non-conformances were identified.Additional information was requested and the following was obtained: the surgeon is not able to provide any further info.The surgeon is familiar with the device having used it for a number of years.

• Brand Name: FLEX 60 ARTICULATING
• 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: 18400736
• MDR Text Key: 331422587
• Report Number: 3005075853-2023-09880
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001706
• UDI-Public: 10705036001706
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081146
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC60A
• Device Lot Number: 446C09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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