inforMED
MalfunctionBWN

LITHOTOMY LEG HOLDER

Received Apr 29, 2021 · Event occurred Mar 24, 2021

Report 1043572-2021-00030 · MDR key 11749907

Device

Generic name

Leg Holder

Product problems

  • Unintended Movement

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE LITHOTOMY LEG HOLDER WAS RETURNED AND EVALUATED BY STERIS, AND IT WAS DETERMINED THAT THE REPORTED EVENT IS ATTRIBUTED TO THE SUPPORT ASSEMBLY ROD NOT BEING FULLY SEATED. AS THE SUPPORT ASSEMBLY ROD WAS NOT FULLY SEATED, THIS ALLOWED FOR THE PIN WHICH LOCKS THE SUPPORT ASSEMBLY ROD IN PLACE TO MISS THE SUPPORT ASSEMBLY ROD AND SLIP OUT OF THE BOSS (CONNECTION POINT). THE TECHNICIAN REPLACED THE LEG HOLDER, TESTED THE UNIT, CONFIRMED IT WAS OPERATING ACCORDING TO SPECIFICATION AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THE USER FACILITY WAS PROVIDED WITH A REPLACEMENT LITHOTOMY LEG HOLDER. THE LITHOTOMY LEG HOLDER IS BEING SENT BACK TO STERIS FOR FURTHER EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR LITHOTOMY LEG HOLDER MOVED DOWNWARD DURING A PATIENT PROCEDURE. THE LITHOTOMY LEG HOLDER WAS REPLACED BY OR STAFF RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.