inforMED
MalfunctionEYD

YELLOWFINS

Received Mar 29, 2013 · Event occurred Mar 11, 2013

Report 3080037 · MDR key 3080037

Device

Generic name

Stirrups

Model number

*

Catalog number

O-YFASI

Lot number

*

Product problems

  • Detachment Of Device Component
  • Loose or Intermittent Connection

Patient

35 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THROUGHOUT PROCEDURE PATIENT WAS POSITIONED IN BILATERAL YELLOW FIN STIRRUPS WITH FOOT OF BED REMOVED. UPON COMPLETION OF SURGICAL PROCEDURE, THE RIGHT YELLOW FIN WAS SQUEEZED IN ORDER TO RAISE IT TO REPLACE FOOT OF BED. AT THIS TIME, WITH THE PATIENT'S LEG STILL IN THE STIRRUP, THE STIRRUP AND STIRRUP HOLDER FELL OFF THE BED. THE HANDLE OF THE STIRRUP HIT THE FLOOR AND THE CST IMMEDIATELY GRABBED THE LEG TO AVOID ANY ROTATION. WITH THE HELP OF THE RN AND CRNA, THE CST WAS ABLE TO REAPPLY THE STIRRUP HOLDER BACK ON THE BED, NOTING THE TIGHTENING KNOB WAS VERY LOOSE. THE HOLDER WAS SECURELY REAPPLIED AND THE STIRRUP WAS PLACED BACK IN THE HOLDER. THE PATIENT'S LEG WAS CAREFULLY REMOVED FROM THE STIRRUP ALONG WITH THE LEFT LEG WITH NO SIGN OF TRAUMA OR DEFORMITY. DR REQUESTED A PORTABLE RIGHT HIP XRAY TO BE TAKEN IN PACU WHICH WAS PERFORMED AND THE SURGEON WAS NOTIFIED OF THE INCIDENT AND FOLLOW-UP CARE. X-RAY WAS NEGATIVE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.