Tissue Pushout Events associated with da Vinci X/Xi SureForm Staplers

A Dear Healthcare Professional Letter has been issued by DTG Medical Pte Ltd to inform healthcare professionals of the potential for injury associated with the use of da Vinci X/Xi SureForm 45, SureForm 45 Curved-Tip and SureForm 60 Staplers during “tissue pushout events”. A “tissue pushout event” occurs when the target tissue fails to remain in place within the jaws of the stapler during the stapler firing sequence, thereby causing some or all of the target tissue to be pushed forward before the staples engage the tissue. If any length of tissue is pushed forward, staples cannot effectively deploy into the moving tissue, resulting in un-approximated transected tissue. Surgical repair of the un-approximated tissue, either through the placement of sutures or the use of surgical stapling, is typically required to complete the procedure. Healthcare professionals are advised to follow the instructions provided in the letter to prevent and manage “tissue pushout events” and to continue to adhere to all instructions, warnings and cautions provided in the SureForm Instruments and Accessories User Manual Addendum. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.