inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 1 (US)

Received Apr 24, 2025 · Event occurred Apr 3, 2025

Report 9611174-2025-00139 · MDR key 21905147

Device

Generic name

Wm-*p2 Series Of Endoscopy Workstations

Model number

K10021764

Product problems

  • Break
  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

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

IT WAS REPORTED THAT THE WHEELS ON THE CART OF THE SUBJECT DEVICE ARE BROKEN. THE ISSUE WAS FOUND DURING SETUP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS REPORT WAS SENT IN ERROR AS THE ISSUE INVOLVING THE BROKEN CART WHEELS WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.