InjuryIDP
TISSUE-TEK CRYO 2000 MICROTOME
Received Oct 27, 2000 · Event occurred Sep 28, 2000
Report 2083544-2000-00002 · MDR key 301959
Device
Generic name
Microtome, Cryostat
Manufacturer
Sakura Finetek U.s.a., Inc.Model number
4705Catalog number
4705
Lot number
NA
Product problems
- Loose
Patient
*
- Surgical procedure aborted/stopped
- Surgical procedure, additional
Narrative
Description of Event or Problem
USER FACILITY CLAIMS THAT THEY WERE UNABLE TO OBTAIN USABLE FROZEN TISSUE SECTIONS (SKIN EXCISIONS) DURING A CANCER PT'S SURGERY TO DETERMINED GRAFT AREA. THE PT'S SURGERY WAS SUSPENDED AND THE MARGINS WERE EVALUATED FROM PARAFFIN SECTIONS. THE PT THEN REQUIRED ADD'L SURGERY FOR GRAFTING. THE USER FACILITY BELIEVES THAT THE KNIFE AND/OR KNIFE HOLDER WAS LOOSENING FROM THE CRYOSTAT MICROTOME AND THEY WERE OBTAINING ALTERNATING THICK AND THIN SECTION (UNUSABLE).
Remedial action
- Replace
- Inspection