inforMED
MalfunctionFLE

AMSCO

Received May 16, 2025 · Event occurred Mar 20, 2025

Report 3005899764-2025-00040 · MDR key 22036157

Device

Generic name

Sterilizer

Catalog number

SR2321211011

Product problems

  • Failure to Align
  • Failure to Align

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN TO THEIR FACE WHILE RETRIEVING A RACK "STUCK" IN THEIR AMSCO 400 STEAM STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE AMSCO 400 STEAM STERILIZER AND FOUND THE CHAMBER TRACK WAS MISALIGNED. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. IT WAS LEARNED THE EMPLOYEE SUBJECT OF THE REPORTED EVENT REACHED INTO THE STERILIZER TO RE-ALIGN THE RACK DURING UNLOADING; ATTRIBUTING TO THE REPORT OF INJURY. THE AMSCO 400 STEAM STERILIZER OPERATOR MANUAL STATES, "BURN HAZARD: STERILIZER, RACK/SHELVES, AND LOADING CAR WILL BE HOT AFTER CYCLE IS RUN. ALWAYS WEAR PROTECTIVE GLOVES AND APRON WHEN REMOVING A PROCESSED LOAD. PROTECTIVE GLOVES AND APRON MUST BE WORN WHEN RELOADING STERILIZER FOLLOWING THE PREVIOUS OPERATION. STEAM MAY BE RELEASED FROM THE CHAMBER WHEN THE DOOR IS OPENED. STEP BACK FROM THE STERILIZER EACH TIME THE DOOR IS OPENED TO MINIMIZE CONTACT WITH STEAM VAPOR." MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.