WM-NP2 WORKSTATION SET 5 - ROW
Received Jul 3, 2023 · Event occurred Jun 4, 2023
Report 9611174-2023-00023 · MDR key 17248541
Device
Generic name
Wm-*p2 Series Of Endoscopy Workstations
Manufacturer
Keymed (medical And Industrial Equipment) LtdModel number
K10021616Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. SECTION B5 WAS UPDATED. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE DEFORMATION COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
THE EVENT OCCURRED DURING TRANSPORTATION.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE AXLE OF THE CASTOR BRAKED (NON-ANTISTATIC) (K10004626) WAS DAMAGED; THE AXLE OF THE CASTOR FREE (ANTISTATIC) (K10005041) WAS DEFORMED; AND THE SHELF CABLE WINDER (K10021187) WAS DEFORMED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED TO OLYMPUS THE CASTOR WAS BROKEN ON THE WM-NP2 WORKSTATION. THE AXLE OF CASTOR BRAKED (K10004626) WAS BROKEN AND THE AXLE OF REAR RIGHT CASTOR (K10005041) WAS DEFORMED. THE PATIENT WAS NOT UNDER SEDATION AND NO DELAY WAS REPORTED. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.