POWER LED RUBINA, OPAL1 NIR/ICG
Received Jul 21, 2026 · Event occurred Jul 6, 2026
Report 2020550-2026-01687 · MDR key 25895004
Device
Generic name
Power Led Rubina, Opal1 Nir/icg
Manufacturer
Karl Storz Se & Co. KgModel number
TL400Catalog number
TL400
Product problems
- Output Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO SURGERY, THE LIGHT SOURCE TURNED OFF AUTOMATICALLY IMMEDIATELY AFTER BEING POWERED ON. THE STORZ SYSTEM WAS RESTARTED; HOWEVER, THE ISSUE PERSISTED. BECAUSE THE ISSUE COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING ATTEMPTS, THE SURGERY WAS CONVERTED TO A LAPAROSCOPIC APPROACH. PATIENT INVOLVEMENT IS UNKNOWN.
Additional Manufacturer Narrative
THE AFFECTED DEVICE IS STILL IN USE AT USER'S FACILITY AND WILL NOT BE RETURNED TO MANUFACTURER FOR EVALAUTION. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).