inforMED
MalfunctionFLE

ATLAS

Received Jun 5, 2025 · Event occurred May 12, 2025

Report 3005899764-2025-00046 · MDR key 22154258

Device

Generic name

Atlas Transfer Carriage

Model number

AX0660230830000013

Catalog number

AX0660230830000013

Product problems

  • Device Dislodged or Dislocated
  • Device Dislodged or Dislocated

Patient

NA · Unknown

  • Laceration(s)
  • Laceration(s)

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE TRANSFER CARRIAGE, LOADING CART AND STERILIZER. THE TECHNICIAN FOUND NO ISSUES WITH THE FUNCTION OR OPERATION OF THE LOADING CART, TRANSFER CARRIAGE, OR STERILIZER. WHILE ONSITE THE TECHNICIAN SPOKE WITH USER FACILITY PERSONNEL AND LEARNED THAT WHEN THE TRANSFER CARRIAGE WAS BEING ENGAGED WITH THE STERILIZER, THE TRANSFER CARRIAGE "SPRUNG" BACK CONTACTING THE EMPLOYEE'S HAND RESULTING IN THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT IS LIKELY ATTRIBUTED TO USER ERROR. THE ATLAS TRANSFER CARRIAGE OPERATOR MANUAL (PG. 3-2) STATES, "ALIGN LOADING CAR AND ATLAS¿ TRANSFER CARRIAGE WITH RAILS INSIDE STERILIZER CHAMBER AND PUSH TRANSFER CARRIAGE FORWARD UNTIL FRONT LATCHES (FIG. 3-1) ARE ENGAGED IN END-FRAME SLOTS (FIG. 3-2)." IN-SERVICE TRAINING IS PENDING ON THE PROPER USE AND OPERATION OF THE ATLAS TRANSFER CARRIAGE. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A SMALL CUT ON THEIR HAND WHILE OPERATING THEIR ATLAS TRANSFER CARRIAGE. THE EMPLOYEE SELF-TREATED BY APPLYING A BANDAGE.

Additional Manufacturer Narrative

STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE ATLAS TRANSFER CARRIAGE; HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.