HISTOCORE AUTOCUT
Received Mar 26, 2026 · Event occurred Mar 4, 2026
Report 8010478-2026-00003 · MDR key 24698856
Device
Generic name
Microtome, Rotary
Manufacturer
Leica Biosystems Nussloch GmbhModel number
HISTOCORE AUTOCUT, CONFIG. 1Catalog number
149AUTO00C1
Product problems
- Use of Device Problem
Patient
NA · Unknown
- Laceration(s)
Narrative
Additional Manufacturer Narrative
AFTER EVALUATION OF THE INFORMATION AVAILABLE, IT WAS FOUND THAT THE ROOT CAUSE OF THE ISSUE WAS THE IMPROPER OPERATION OF THE DEVICE. IN ORDER TO MITIGATE THE RISK OF A RECURRENCE OF THIS INCIDENT, A RETRAINING ON MICROTOME SAFETY WAS CARRIED OUT AND SUCCESSFULLY COMPLETED BY THE FIELD SERVICE ENGINEER ON (B)(6) 2026. THE PREVENTIVE MAINTENANCE OF THE HISTOCORE AUTOCUT SERIAL, NUMBER (B)(6), WAS CONCLUDED ON (B)(6) 2026, WITH ONLY REGULAR YEARLY MAINTENANCE BEING REQUIRED. THE DEVICE WAS FOUND TO BE FUNCTIONING AS INTENDED. NO PATIENT SAMPLES WERE NEGATIVELY AFFECTED.
Description of Event or Problem
ON (B)(6) 2026, LEICA BIOSYSTEMS WAS INFORMED THAT WHILE PERFORMING A ROUTINE PREVENTIVE MAINTENANCE OF THE HISTOCORE AUTOCUT SERIAL, NUMBER (B)(6), AT THE CUSTOMER SITE, THE LEICA BIOSYSTEMS SERVICE ENGINEER CARRYING OUT THE WORK WAS INJURED. ON MARCH 5TH, 2026, THE FIELD SERVICE ENGINEER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE INJURY WAS A CUT TO THE FINGER ON A DIRTY BLADE THAT WAS STILL IN THE DEVICE WHEN THE FSE CARRIED OUT THE PREVENTIVE MAINTENANCE. THE INJURY REQUIRED A VISIT TO URGENT CARE. WHILE AT URGENT CARE THE FIELD SERVICE ENGINEER RECEIVED A REFRESHER OF HER TETANUS VACCINATION. NO FURTHER INFORMATION WAS DISCLOSED.