inforMED
MalfunctionFLE

AMSCO

Received Mar 18, 2026 · Event occurred Feb 17, 2026

Report 3005899764-2026-00022 · MDR key 24627720

Device

Generic name

Sterilizer

Catalog number

EF1101142

Product problems

  • Device Slipped

Patient

NA · Unknown

  • Abrasion

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE BRACKETS OF THE RACK AND SHELF ASSEMBLY WERE BENT CAUSING THE SHELVES TO SLIP OFF. TO RESOLVE THE ISSUE, THE TECHNICIAN ORDERED A NEW RACK AND SHELF ASSEMBLY. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE REPAIRS HAVE BEEN MADE. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS UNLOADING INSTRUMENTS FROM THEIR AMSCO 600 STERILIZER, A LOADED SHELF SLIPPED OFF BRACKET AND CONTACTED THE EMPLOYEE'S HAND RESULTING IN A BRUISE. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

THE TECHNICIAN REPLACED THE RACK AND SHELF ASSEMBLY, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.