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 09/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 11/21/2023.D4: batch # 268c29.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 joint cover damaged and with an ecr60b reload loaded.Also, an unknown trocar was returned and inserted in the shaft of the device.The reload was received fully fired, the device was tested for functionality in the articulated position with a test reload and achieved its complete firing sequence without any difficulties noted during the functional testing, the device opened and closed as expected.The staple line and cut line were complete and the staples meet the staple release criteria.Although no conclusion could be reached on the cause of the reported event, 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.The instrument can only achieve a maximum articulation angle of 45º.When using body structures or organs as a grounding surface, particular attention should be placed to the visual cues and tactile feedback received from the instrument.When the maximum angle is reached, the force will increase indicating the maximum angle has been reached.Avoid applying excessive pressure to the tissue as tissue damage or tissue trauma may occur.Ensure that the tissue lies flat and is positioned properly between the jaws.Any ¿bunching¿ of tissue along the reload, particularly in the crotch of the jaws, may result in an incomplete staple line.The event could not be confirmed as the device performed as expected and during the functional testing, the device opened and closed without any difficulties noted.The damaged on the joint cover, it is possible that the device was attended to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.Please reference the instruction for use for more information.Device history review: pending a manufacturing record evaluation was performed for the finished device batch number 268c29, and no non-conformances related to the reported complaint condition were identified.Additional information was requested and the following was obtained: what trouble shooting steps were taken during this event? tried reverse button.Which firing of the device did the event occur? 1st fire was there any difficulty with the 4th stroke of the device? unknown.Were all 4stokes completed? no.What type of tissue was being fired upon? unknown.What was the surgical procedure? colorectal surgery.Was the device difficult to close? no.Was the device difficult to fire? yes, partial fire.Why was the procedure converted to open instead of continuing the procedure laparoscopically? could not open the jaw, so changed to open operation, cut the tissue and removed the device.Update event description: could not reverse the knife and could not open the jaw.This case is from health authority.It was reported that during the operation, after the fire, could not reverse the knife or open the jaw.Changed to open operation, cut some tissue and removed the device.

Event Description

It was reported that during an unk procedure, the reload could not return to the straight position, and was difficult to remove from the body.No additional information can be provided.

• 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 ; PR ; 3035526892
• MDR Report Key: 18188630
• MDR Text Key: 328738603
• Report Number: 3005075853-2023-08667
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001706
• UDI-Public: 10705036001706
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2023

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC60A
• Device Lot Number: 299C41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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
• Patient Outcome(s): Required Intervention