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

Catalog Number EC60A

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

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that during an unk procedure, the device opening button was stuck and not working.No patient consequences were reported.

Manufacturer Narrative

(b)(4).Date sent: 11/17/2023.D4: batch # 639a19.B3: exact event date unk, entered 1/1/2023 as only the year was provided.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 revealed that one ec60a device was returned with no apparent damage and with no reload present.The device was tested for functionality in the articulated position with a test reload and achieved its complete firing sequence without any difficulties noted.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.If the instrument locks out, the stroke count indicator will display a lockout symbol.Stop and push the red manual knife reverse switch downward to reverse the knife motion; the knife direction indicator will display an arrow pointing towards the proximal end of the instrument to indicate the knife is in the return mode.Squeeze firing trigger (2) completely until it rests on the closing trigger.The stroke count indicator will display ¿0¿ to indicate the knife has returned to its home position.Then press the anvil release button to release the jaws from the tissue.Close the instrument jaws by pressing the closing trigger (1), remove the instrument, and replace the cartridge.Firing through the lockout mechanism will break the instrument.The event described could not be confirmed as the device performed without any difficulties noted and no cartridge was returned for analysis.Device history review a manufacturing record evaluation was performed for the finished device batch number 639a19, and no non-conformances were identified.Additional information was requested and the following was obtained: was the device locked on tissue with the jaws closed? if yes, how was the device removed? what troubleshooting steps were attempted to open the device (e.G.Squeezing the closing trigger while simultaneously depressing the anvil release button, knife reverse switch, manual override)? did the jaws eventually open?.

• 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 ; * ; 3035526892
• MDR Report Key: 18164195
• MDR Text Key: 328442289
• Report Number: 3005075853-2023-08557
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001706
• UDI-Public: 10705036001706
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: X94A9E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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