Inadvertent instrument lockout during surgical procedures involving ENDOPATH ECHELON™ Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row)

A Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte Ltd to inform healthcare professionals about an increase in reports regarding inadvertent instrument lockout during surgical procedures involving ENDOPATH ECHELON™ Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row), product code VASECR35. This reload is used exclusively with the ECHELON™ Flex Powered Vascular Stapler, product code PVE35A. If a user encounters the lockout issue, the device will momentarily activate but will not cut or staple tissue. Additional steps will be required to open and remove it from tissue as per the Instructions for Use (IFU). However, if the user is unable to or unsure of how to complete the necessary actions to remove the device from tissue, potential harms may include additional surgical delay, bleeding/ haemorrhage, life threatening haemorrhage/ haemorrhagic shock, and conversion to open surgery. Two adverse events have been received, including one patient death, where the user experienced an inadvertent lockout and had difficulties opening the device which may have contributed to the negative patient outcomes. Healthcare professionals who have treated patients using the affected product are advised to follow these patients post-operatively in the usual manner with no additional action required. It is recommended to refer to the mitigating instructions in the IFU and attached letter to address lockouts. Please refer to the letter for details.

Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

9 May 2025

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Step 2: Click on 'Restricted Content' and log in via SingPass.

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Step 4: Click on the Drug Alert tab to view the DHCPLs.