inforMED
MalfunctionCCX

YELLOWFIN STIRRUP

Received Feb 19, 2019 · Event occurred Dec 20, 2018

Report 8349403 · MDR key 8349403

Device

Generic name

Support, Patient Position

Catalog number

O-YFASI

Product problems

  • Break
  • Device Slipped
  • Component Missing

Patient

21170 DA

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WHILE PLACING ROBOTIC PORTS, RIGHT STIRRUP HINGE BROKE AND FELL TO THE GROUND WHILE THE PATIENT WAS IN FULL TRENDELENBERG POSITION. SURGICAL TECH PICKED UP PATIENT'S LEG AS SOON AS POSSIBLE AND ATTENDING SURGEON WAS NOTIFIED. RIGHT STIRRUP WAS REPLACED. EVALUATION OF THE DEVICE SHOWED THAT ONE OF THE PINS THAT ENGAGES THE LOCKING MECHANISM WAS MISSING AND THE OTHER PIN WAS BACKED OUT OF THE HOLE ENOUGH TO DISENGAGE, CAUSING THE LEG HOLDER TO FALL. NO PATIENT INJURY WAS NOTED.