M525 F40
Received Dec 5, 2025 · Event occurred Oct 17, 2025
Report 3003974370-2025-00010 · MDR key 23725448
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CHINA STATING THAT AN M525 F40 SPORADICALLY SHUT DOWN DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
THIS IS A COMBINED INITIAL/FINAL REPORT. THE FSE INVESTIGATED THE AFFECTED DEVICE AND DETERMINED THAT THE FAN INPUT AND OUTPUT OPENINGS OF THE MAIN POWER SUPPLY WERE COVERED WITH EXCESSIVE DIRT. THIS HEAVILY CONTAMINATION SUBSEQUENTLY LED TO SPORADIC SHUTDOWNS OF THE DEVICE. AFTER CLEANING THE MICROSCOPE, THE PROBLEM WAS RESOLVED. SINCE NO COMPONENT WAS DEFECTIVE, NO PART REPLACEMENT WAS NECESSARY. A REVIEW OF THE SERVICE RECORDS REVEALED NO EVIDENCE OF PROBLEMS THAT COULD BE ASSOCIATED WITH THE REPORTED INCIDENT. IT WAS FOUND THAT THE AFFECTED UNIT, WHICH IS OVER 11 YEARS OLD, HAD NOT UNDERGONE REGULAR MAINTENANCE. A REVIEW OF THE COMPLAINT STATISTICS DID NOT SHOW ANY SIMILAR OR IDENTICAL CASE. THE REPORTED MALFUNCTION IS CONSIDERED AN ISOLATED EVENT AND DOES NOT INDICATE A DESIGN OR MANUFACTURING ISSUE. THE CAUSE OF THE REPORTED PROBLEM CAN BE TRACED TO INADEQUATE MAINTENANCE. THE DEVICE HAS BEEN SERVICED, AND THE AIR INPUT AND OUTPUT OPENINGS OF THE POWER SUPPLY FANS HAVE BEEN CLEANED. FOLLOWING THE SERVICE, THE UNIT IS OPERATING WITHIN SPECIFICATIONS. THE CUSTOMER HAS INDICATED THAT THEY DO NOT WISH TO HAVE THE ANNUAL MAINTENANCE PERFORMED BY AN AUTHORIZED FSE.