MalfunctionFBP
TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLE
Received Jan 12, 2024 · Event occurred Dec 29, 2023
Report 9610773-2024-00159 · MDR key 18508340
Device
Generic name
Telescope, Rigid, Endoscopic
Manufacturer
Olympus Winter & Ibe GmbhModel number
WA2T430ALot number
805128B
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.
Description of Event or Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE "OES ELITE", 4 MM, 30°, HIGH DEFINITION HAD A BROKEN LENS. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.