inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 1 (JP)

Received Apr 24, 2025 · Event occurred Apr 10, 2025

Report 9611174-2025-00138 · MDR key 21900221

Device

Generic name

Wm-*p2 Series Of Endoscopy Workstations

Model number

K10021766

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

IT WAS REPORTED THAT THE WORKSTATION'S CASTOR WAS BROKEN. THE ISSUE OCCURRED DURING PREPARATION AND SET UP. THE DEVICE WAS INSPECTED PRIOR TO USE. THERE WAS NO REPORT OF PATIENT HARM.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Additional Manufacturer Narrative

THIS REPORT WAS SENT IN ERROR AS A DAMAGED CASTOR WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR.