inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 1 (US)

Received Dec 11, 2024

Report 9611174-2024-01705 · MDR key 20904366

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

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN CASTOR WHEEL. THE ISSUE WAS IDENTIFIED AT INSPECTION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

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

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