inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 4 (US)

Received Jun 2, 2023 · Event occurred May 4, 2023

Report 9611174-2023-00018 · MDR key 17054338

Device

Generic name

Endoscopy Workstation

Model number

K10021611

Product problems

  • Break
  • Break

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Description of Event or Problem

THE CUSTOMER RETURNED THE WM-NP2 WORKSTATION TO OLYMPUS REPAIR CENTER FOR EVALUATION OF A REPORTED CASTOR THAT WAS SHEARED OFF AT THE BOLT. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO UPDATE SECTIONS H4 AND H6. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE SHEARED CASTOR CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO METAL FATIGUE. HOWEVER, THE DEFINI9TIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.