KARL STORZ AIDA

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OUR US FACILITY ON JAN-30-2025, AND WILL LATER BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. 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 (CASE TYPE INFORMATION WAS NOT PROVIDED), THE RECORDING DEVICE IMAGE CUT OFF AND THE SCREEN GOES BLACK. THE DEVICE THEN SHUT OFF ITSELF AND CANNOT BE RESTARTED. SINCE THIS DEVICE IS RECORDING DEVICE, THEY WERE STILL ABLE TO COMPLETE THE PROCEDURE USING THE MAIN OR MONITOR WITHOUT ANY PATIENT IMPACT,

Additional Manufacturer Narrative

THE DEVICE WAS SENT TO THE MANUFACTURER FOR INSPECTION. DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER," REPORTED ISSUE: THE IMAGE CUTS OFF AND THE SCREEN GOES BLACK. THE LAST TIME THE UNIT WAS USED ON (B)(6) 2025, IT WAS DURING PATIENT USE. THE AIDA SHUT OFF IN THE MIDDLE OF THE CASE AND COULD NOT BE RESTARTED AFTER." COULDN'T BE CONFIRMED. NO MALFUNCTION PRESENT. DEVICE FUNCTIONS PERFECTLY ACCORDING TO SPECIFICATIONS. THE ABOVE INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE, OR ITS HISTORY. ALL PRODUCTION-RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICE'S MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY DID NOT REVEAL ANY PICKUP IN SIMILAR COMPLAINTS; NO TREND WAS IDENTIFIED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).