WM-NP2 WORKSTATION SET 5 (EU)

Additional Manufacturer Narrative

OLYMPUS WILL FURTHER INVESTIGATE THE CASE IN ORDER TO ASSESS THE INCIDENT.

Description of Event or Problem

THE WM-NP2 WORKSTATION IS INTENDED TO ASSIST ENDOSCOPIC PROCEDURES USING OLYMPUS MEDICAL DEVICES AND THEIR ACCESSORIES WITHIN MEDICAL FACILITIES BY PROVIDING A STABLE MAINS POWER SUPPLY AND A PLATFORM FOR THE USE AND HANDLING OF THE DEVICES DURING ENDOSCOPIC DIAGNOSTIC AND THERAPEUTIC PROCEDURES. IF EQUIPPED WITH A MONITOR, THE WM-NP2 WORKSTATION ALLOWS VISUALISATION DURING THE PROCEDURE. IT WAS REPORTED, THAT THE CASTOR HAS BROKEN OFF. NO ADDITIONAL INFORMATION WERE RECEIVED, AS THE DEVICE WAS ONLY SENT BACK FOR REPAIR.

Additional Manufacturer Narrative

THE OLYMPUS KEYMED INVESTIGATION HAS BEEN COMPLETED. A REQUEST WAS MADE FOR THE FAULTY CASTOR TO BE RETURNED FOR FURTHER INVESTIGATION, HOWEVER IT WAS NOT RECEIVED. THE INVESTIGATION WAS COMPLETED BASED ON THE INFORMATION PROVIDED AND SIMILAR REPORTED COMPLAINTS. THE OUTCOME OF THE INVESTIGATION WAS THAT THE WORKSTATION HAD NOT BEEN MAINTAINED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). SHOULD THE FAULTY CASTOR BE RECEIVED A FURTHER INVESTIGATION WILL BE RAISED AND A SUPPLEMENTARY REPORT SUBMITTED. H3 OTHER TEXT : CASTOR RETURN REQUESTED BUT NOT RECEIVED BY LEGAL MANUFACTURER.