OR1 RACK KONFIGURIERT, NEO, 40 BIS 47HE
Received Dec 16, 2022 · Event occurred Nov 30, 2022
Report 2020550-2022-00335 · MDR key 15997264
Device
Generic name
Or1 Rack Konfiguriert
Manufacturer
Karl Storz Se & Co. KgProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE EVENT OCCURRED IN GERMANY. AFTER CONSULTING WITH THE NURSING STAFF PRESENT IN THE ROOM, THEY HAD PREVIOUSLY EXPERIENCED SIGNAL PROBLEMS ON SOME MONITORS. HOWEVER, AFTER RESTARTING THE SYSTEM, THESE WERE RESOLVED, AND THE SURGERY WAS STARTED. SHORTLY AFTER THE PROCEDURE BEGAN, THE IMAGE SIGNAL FAILED ON ALL MONITORS. THE AV CONTROL LIGHT WAS NOT ACTIVE. HOWEVER, THE DOCUMENTATION (AIDA) CONTROL LIGHT REMAINED ON. THE BACKUP LINE WAS NOT USED. THE CAMERA SYSTEM AND ENDOSCOPIC EQUIPMENT WERE FUNCTIONAL AND OPERATING. THE PATIENT WAS STERILELY DRAPED AND TAKEN TO ANOTHER OR TO COMPLETE THE SURGERY. NO FURTHER NEGATIVE IMPACT WAS REPORTED.
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).