inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 3 (JP)

Received Dec 30, 2024

Report 9611174-2024-01726 · MDR key 21035594

Device

Generic name

Wm-*p2 Series Of Endoscopy Workstations

Model number

K10020682

Product problems

  • Break
  • Break

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL 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 SUBJECT DEVICE HAD CASTOR DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS REPORT WAS SENT IN ERROR AS CASTOR DAMAGED 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.