OR1 NEO IP, BAS
Received May 14, 2025 · Event occurred Apr 26, 2025
Report 2020550-2025-00847 · MDR key 22020818
Device
Generic name
Or1 Neo Ip, Bas
Manufacturer
Karl Storz Se & Co. KgModel number
WUIS2545Catalog number
WUIS2545
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, WE WILL SEND OUR SERVICE TECH TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, A SURGICAL DISPLAY FELL ON A CLINICAL STAFF MEMBER. NO TREATMENT WAS PROVIDED TO THAT STAFF AFTER THE INCIDENT, AND WE WERE TOLD THAT SHE IS DOING FINE.