WM-NP2 WORKSTATION SET 4 (JP)
Received Mar 3, 2025
Report 9611174-2025-00081 · MDR key 21502269
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021610Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1(FACILITY NAME): (B)(6) HOSPITAL. 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 SUBJECT DEVICE HAD A DAMAGED CASTER. THE ISSUE OCCURRED DURING INSPECTION FOR USE BEFORE THE PATIENT ENTERED THE ROOM. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTIONS TO THE INITIAL REPORT. THIS REPORT WAS SENT IN ERROR 'CASTOR DAMAGED' WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVDE FROM THE CUSTOMER.