AIDA
Received Aug 12, 2024 · Event occurred Aug 1, 2024
Report 9610617-2024-00290 · MDR key 19961847
Device
Product problems
- Unexpected Shutdown
- Unintended Application Program Shut Down
- Unexpected Shutdown
- Unintended Application Program Shut Down
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS PROVIDED IN SECTION B5 AND SECTION D10. THE LEADING PRODUCT IN THIS EVENT IS NOT SOLD IN THE U.S AND THEREFORE NOT REPORTABLE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
THE CUSTOMER INITIALLY REPORTED PRODUCT NO. WD200. A SERVICE TECHNICIAN HAS JUST CALLED AND INFORMED US THAT HE WAS AT THE END CUSTOMER. ACCORDING TO HIS STATEMENT, WEAR ON THE MAIN SWITCH WAS THE CAUSE OF THE DEFECT: HSK TOWER FAILED DURING THE INSPECTION. SINCE THE INITIAL REPORTED DEVICE IS NOT CAUSE OF THE FAULT BUT ACCORDING TO THE SERVICE TECHNICIAN THE SWITCH OF THE HSK TOWER, THE LEADING PRODUCT IN THIS REPORT WAS CHANGED TO THE HSK TOWER. THE MALFUNCTIONING PRODUCT WAS FURNITURE AND NOT A MEDICAL DEVICE. THEREFORE, THIS EVENT IS NOT REPORTABLE.
Additional Manufacturer Narrative
KARL STORZ WAS INFORMED ABOUT AN INCIDENT WITH A WD200 (SERIALNUMBER: (B)(6), MANUFACTURING MONTH & YEAR: SEPTEMBER 2017). A SERVICE TECHNICIAN WAS AT THE END CUSTOMER. ACCORDING TO HIS STATEMENT, WEAR ON THE MAIN SWITCH WAS THE CAUSE OF THE DEFECT: HSK TOWER FAILED DURING THE INSPECTION. SINCE THE INITIAL REPORTED DEVICE IS NOT THE CAUSE OF THE FAULT, BUT ACCORDING TO THE SERVICE TECHNICIAN THE SWITH OF THE HSK TOWER, THE LEADING PRODUCT IN THIS REPORT WAS CHANGED TO THE HSK TOWER (END OF PRODUCTION: JANUARY 31, 2014.). THE CAUSATIVE MAINS SWITCH WAS RETURNED ON 09.09.2024. THE SWITCH DOES NOT SWITCH PROPERLY AND IS WORN. THE CUSTOMER STATED THAT THE EQUIPMENT CART HAD CAUSED PROBLEMS ON SEVERAL OCCASIONS PRIOR TO THE REPORTED INCIDENT. DURING THE ANNUAL MAINTENANCE ACCORDING TO THE IFU, THIS SHOULD HAVE BEEN NOTICED. 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 INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE FAILED DURING THE SURGERY AND A CRACKING NOISE COULD BE HEARD. THE SURGERY HAD TO BE CANCELED.