inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 3 (ROW)

Received Feb 11, 2026 · Event occurred Jan 16, 2026

Report 9611174-2026-00043 · MDR key 24317066

Device

Generic name

Wm-*p2 Series Of Endoscopy Workstations

Model number

K10020681

Product problems

  • Break

Patient

NA · Unknown

  • 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 WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS HAD CASTER DAMAGE. THE ISSUE WAS FOUND DURING THE SERVICE. THERE WERE NO REPORTS OF PATIENT HARM.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, H2, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE CASTER DAMAGE WAS CAUSED BY A COMPONENT FAILURE OF THE CASTOR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.