inforMED
MalfunctionFLE

CENTURY STERILIZER

Received Jan 3, 2025 · Event occurred Nov 29, 2024

Report 3005899764-2025-00001 · MDR key 21069687

Device

Generic name

Sterilizer

Product problems

  • Break
  • Break

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE LOWER ACCESS PANEL ON THEIR MEDIUM CENTURY STERILIZER BROKE OFF AND CONTACTED AN EMPLOYEE'S FOOT. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE UNIT AND FOUND THAT THE MAGNETS ON THE UNIT WERE WORN OUT, AND THE BRACKETS ON THE MAGNETS WERE BENT. THE TECHNICIAN REPLACED THE MAGNETS AND ADJUSTED THE BRACKETS, TESTED THE STERILIZER, CONFIRMED IT TO BE OPERATIONAL, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.