inforMED
InjuryFLE

MST-V 6-0-12 VS1

Received Sep 14, 2024 · Event occurred Jul 29, 2024

Report 3001061128-2024-00004 · MDR key 20219482

Device

Generic name

Sterilizer

Manufacturer

Belimed Ag

Lot number

2013584

Product problems

  • Failure to Align
  • Failure to Align

Patient

NA · Unknown

  • Muscle/Tendon Damage
  • Muscle/Tendon Damage

Narrative

Additional Manufacturer Narrative

AT THE TIME OF THE INCIDENT, THE DOCKING PLATES FOR THE BATCH CARTS WERE MISALIGNED WITH THE HEIGHT OF THE CARTS, MAKING IT IMPOSSIBLE TO EASILY ROLL THE RACKS OUT OF THE STERILIZER AND ONTO THE CARTS AS INTENDED. THE MISALIGNMENT WAS NOT DUE TO NONCONFORMING OR FAULTY PARTS. STERILIZER DOCKING PLATE HEIGHT HAS BEEN READJUSTED AND TESTING WAS CARRIED OUT TO ENSURE SMOOTH TRANSITION OF RACKS FROM THE STERILIZER TO THE CART.

Description of Event or Problem

THE SPD MANAGER REPORTED THAT AN EMPLOYEE'S SHOULDER WAS INJURED WHILE TRYING TO LIFT A STERILIZER RACK FROM THE CHAMBER ONTO THE TRANSPORT CART. THE EMPLOYEE WENT TO THE EMERGENCY DEPARTMENT TO GET CHECKED OUT BUT WAS NOT HOSPITALIZED. AS OF (B)(6) 2024 THE EMPLOYEE HAS NOT RETURNED TO WORK AND IS NOT ABLE TO DRIVE NOR TO LIFT THEIR ARM. THE INCIDENT IS BEING HANDLED BY THE FACILITY'S OCCUPATIONAL CARE AND THE INJURED INDIVIDUAL IS CURRENTLY AWAITING AN MRI.

Remedial action

  • Modification/Adjustment