Tissue-Tek AutoSection® 5010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00615233079350), received between Jul 12, 2022 and Jul 25, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAKURA FINETEK THIRD PARTY SERVICE PROVIDER WAS DISPATCHED TO A CUSTOMER SITE ON 7/12/2023 TO PERFORM THE PREVENTIVE MAINTENANCE ON TISSUE-TEK AUTOSECTION SERIAL# (B)(6). THE CUSTOMER INFORMED THEM THAT APPROXIMATELY 3-4 MONTHS AGO, WHILE WORKING WITH THE BLADE HOLDER OF TISSUE-TEK AUTOSECTION, THE MICROTOME ACTIVATED AND THE HEAD DROPPED, RESULTING IN CUSTOMER RECEIVING 5 STITCHES ON THUMB. THE INCIDENT OCCURRED ON (B)(6) 2023 BUT WAS REPORTED TO SAKURA FINETEK ON 07/13/2023 BY THE THIRD PARTY SERVICE PROVIDER. THE CUSTOMER DID NOT CONSIDER REPORTING THIS TO SAKURA AT THE TIME AND CONTINUED USING THE INSTRUMENT WITHOUT FURTHER INCIDENT AND NO CAUSE WAS DETERMINED OF HOW THIS HAPPENED.

  Patient problems: Laceration(s)

  MAUDE report 17390475 ↗
• InjuryJul 12, 2022Device Handling Problem; Device Handling Problem

  SAKURA FINETEK WAS NOTIFIED OF AN INCIDENT ON (B)(6) 2022 WHICH OCCURRED ON (B)(6) 2022 WITH THE AUTOSECTION INSTRUMENT, SERIAL NO. (B)(4). INCIDENT OCCURRED DURING INSTALLATION OF INSTRUMENT. WHILE SETTING UP THE AUTOSECTION INSTRUMENT, SAKURA FIELD APPLICATION SPECIALIST NOTICED THE BLOCKS THAT THE CLIENT USED WERE BIGGER THAN THE NORMAL CASSETTES USED; THEREFORE, SAKURA EMPLOYEE PUT ONE OF THE CLIENT'S CASSETTE IN THE UNIT TO ENSURE IT WOULD CLEAR THE BLADE HOLDER. EMPLOYEE PRESSED THE ALIGN BUTTON AND REALIZED HE DID NOT WANT TO CUT INTO THE CLIENT'S BLOCK, SO THE EMPLOYEE TRIED TO GRAB THE CASSETTE BEFORE THE UNIT STARTED. THE UNIT STARTED AND BROUGHT EMPLOYEE'S FINGER ON THE BLADE CAUSING A DEEP CUT ACROSS THE TIP OF EMPLOYEE'S LEFT THUMB.

  Patient problems: Laceration(s)

  MAUDE report 14988015 ↗