inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 4 (US)

Received Nov 22, 2022

Report 9611174-2022-00034 · MDR key 15848221

Device

Generic name

Wm-*p2 Series Of Endoscopy Workstations

Model number

K10021611

Product problems

  • Break
  • Break

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

UPON FURTHER EVALUATION, SERVICE FOUND NORMAL WEAR AND TEAR ON THE HOUSING. THE INVESTIGATION IS ONGOING; THEREFORE, A ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Description of Event or Problem

THE OLYMPUS DEMO ASSET DEVICE WAS SENT IN FOR INSPECTION. THERE WAS NO PATIENT OR USER INJURY REPORTED. UPON INSPECTION AND TESTING, SERVICE FOUND THE RIGHT CASTOR WAS DAMAGED.