MalfunctionFEM

WM-NP2 WORKSTATION SET 5 (EU)

Received Apr 28, 2021 · Event occurred Apr 13, 2021

Report 9611174-2021-00014 · MDR key 11737160

Device

Generic name

Wm-*p2 Series Of Endoscopy Workstations

Manufacturer

Keymed (medical And Industrial Equipment) Ltd.

Model number

K10021613

Product problems

Break

Patient

Not reported

Insufficient Information
No Clinical Signs, Symptoms or Conditions
Insufficient Information
No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

OLYMPUS KEYMED INVESTIGATION HAS BEEN COMPLETED. THE PHOTOS PROVIDED OF THE FAILURE SHOWED THAT THE CASTORS HAD RECEIVED MULTIPLE IMPACTS AND THAT THE LOCKING NUT AND HAD NOT BEEN SUFFICIENTLY TIGHTENED. THIS INDICATED THAT THE 6 MONTHLY CHECKS ON THE CASTORS HAD NOT BEEN CARRIED OUT AS PER THE INSTRUCTIONS FOR USE. FAILURE CAUSED BY USER AND LACK OF REGULAR MAINTENANCE.

Additional Manufacturer Narrative

OLYMPUS KEYMED INVESTIGATION IN PROGRESS. HAVE REQUESTED THAT THE FAILED CASTORS ARE RETURNED FOR FURTHER INVESTIGATION.

Description of Event or Problem

DURING A PROCEDURE THE CASTORS ON THE WM-NP2 WORKSTATION BROKE OFF. THERE WAS NO REPORT OF INJURY TO PATIENT OR USER. A SUPPORT WAS PLACED UNDER THE BASE AND THE PROCEDURE WAS COMPLETED.