inforMED
MalfunctionCCX

YELLOFINS STIRRUP

Received Apr 27, 2020 · Event occurred Nov 22, 2019

Report 10000438 · MDR key 10000438

Device

Generic name

Support, Patient Position

Model number

O-YFASI

Product problems

  • Detachment of Device or Device Component

Patient

16060 DA

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

RIGHT LEG STIRRUP CAME OUT OF BRACKET WITH PATIENT'S LEG IN THE STIRRUP. THE STIRRUP CAME OUT OF THE STIRRUP HOLDER DURING SURGERY. SURGEON WAS STANDING NEXT TO LEG AND WAS ABLE TO HOLD LEG AND IT WAS AT THE END OF THE CASE. NO HARM TO THE PATIENT. BIOMED TECH TESTED YELLOFINS STIRRUPS. CONNECTED BOTH BRACKETS TO SURGERY BED. BRACKETS TIGHT AND STIRRUP WAS MOVED TO DIFFERENT DIRECTIONS. UNIT WAS STEADY WITH NO ISSUES. STIRRUPS RETURNED TO SERVICE.