KARL STORZ AIDA

Additional Manufacturer Narrative

DEVICE EVALUATION: IT IS CONCLUDED THAT OF THE REPORTED DEVICES, THE DEVICE WD300 (KARL STORZ AIDA) IS MOST LIKELY THE CAUSATIVE DEVICE FOR THE DESCRIBED EVENT. THE DEVICES WERE NOT AVAILABLE FOR INVESTIGATION. THEREFORE, THE INVESTIGATION IS BASED ON THE AVAILABLE EVENT DESCRIPTION, HISTORICAL DATA AND THE EXPERIENCE OF THE INVESTIGATOR. THE REPORTED ISSUE "LOSS OF IMAGE ON SURGICAL MONITOR X 2 LOTS (OR1AIR) HAPPENED AT THE SAME TIME IN THE SAME THEATRE ON THE SAME PATIENT. TEMPORARY BLANK SCREEN (APPROX. 15 SECONDS) WHILST SURGERY WAS IN PROGRESS. FAULTY MONITOR - FURTHER INVESTIGATION NEED AS THIS MAY ALSO BE AS A RESULT OF AN ISSUE WITH THE TC201EN, OR TH120, OR OR1AIR (WD300 / AVM)" COULD HAVE DIFFERENT CAUSES. DUE TO LIMITED AVAILABLE INFORMATION NO SOFTWARE VERSIONS OR LOG FILES COULD BE CHECKED. THIS ALSO LIMITS THE POSSIBILITIES FOR THE INVESTIGATION. THE MOST PROBABLE ROOT CAUSE IS A SOFTWARE MALFUNCTION OF THE LOOP THROUGH FUNCTION OF THE WD300 (AIDA). THIS IS CONCLUDED BASED ON THE RECEIVED DESCRIPTION STATING AN IMAGE LOSS OF APPROX. 15 SEC. THIS IS THE TIME THE BACKUP NEEDS TO GET UP AND RUNNING UNTIL IT WILL PROVIDE THE LIVE IMAGE ON A SECURE LINE. DUE TO THE AGE OF THE WD300 AND THE DESCRIPTION OF THE EVENT, IT IS ASSUMED, THAT A PREVIOUS SOFTWARE VERSION WAS RUNNING ON THE DEVICE (VERSION 1.5.0.7 WAS INSTALLED AT TIME OF DELIVERY) AT THE TIME OF THE EVENT. CURRENT SOFTWARE VERSION FOR THIS PRODUCT IS 1.8.2 AND WITH THIS CURRENT SOFTWARE, THE LOOP THROUGH ISSUE IS SOLVED. BASED ON THESE CONCLUSIONS REGARDING THE PRODUCT WD300, IT IS ALSO CONCLUDED THAT PRODUCT TC201 (IMAGE1 S CONNECT II) IS MOST LIKELY NOT CAUSATIVE. USUALLY IF THE IMAGE FAILS ON THE TC201, THE LOSS IS MORE THAN 15 SEC. THE TWO TM340 MONITORS ARE ALSO DETERMINED TO BE NOT CAUSATIVE, BECAUSE IT IS MOST UNLIKELY THAT BOTH MONITORS SHOW THE SAME DEFECT SIMULTANEOUSLY. PRODUCT TH120 (IMAGE1 S 4U) SEEMS NOT TO BE CAUSATIVE BECAUSE IF THERE IS A FAILURE OF THE TH120, ACCORDING TO THE INVESTIGATOR'S EXPERIENCE, THE IMAGE LOSS WOULD BE LESS OR MORE THAN 15 SEC. AND PRODUCT WM200 (OR1 SMARTSCREEN) IS ALSO EXCLUDED AS A CAUSE, BECAUSE ACCORDING TO THE EVENT DESCRIPTION, THE REPORTER DID NOT CLAIM THE BLACKOUT ON THIS MONITOR. CROSS REFERENCE MDR: 9610617-2025-00147; 9610617-2025-00148. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT LOSS OF IMAGE ON SURGICAL MONITOR 2 LOTS OR1AIR HAPPENED AT THE SAME TIME IN THE SAME THEATRE ON THE SAME PATIENT. THERE WAS A TEMPORARY BLANK SCREEN FOR APPROX. 15 SECONDS WHILST SURGERY WAS IN PROGRESS THERE WAS A FAULTY MONITOR - FURTHER INVESTIGATION NEEDED AS THIS MAY ALSO BE AS A RESULT OF AN ISSUE WITH THE TC201EN, OR TH120, OR OR1AIR (WD300 / AVM). NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-00147. 9610617-2025-00148.