MalfunctionNNK
TISSUE-TEK®
Received Apr 3, 2024 · Event occurred Sep 12, 2023
Report 19031495 · MDR key 19031495
Device
Generic name
Container, Specimen Mailer And Storage, Non-sterile
Manufacturer
Sakura Finetek U.s.a., Inc.Model number
4223Catalog number
4223
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MESH BIOPSY BAGS ARE USED TO HOLD TISSUES WHEN GROSSING TO KEEP THEM SAFE, BEFORE BEING INSERTED INTO CASSETTES. THE CURRENT MESH BAGS ARE TEARING APART AT THE EDGES WHEN OPENING THEM TO PUT TISSUES IN AND NOT HOLDING THEIR SHAPE. THIS GIVES TISSUES THE POTENTIAL TO BE LOST OUT THE SIDE OF THESE BAGS. THERE HAS BEEN AN INCREASED NUMBER OF BAGS TEARING APART AT THE EDGES CAUSING THE GROSSING TECH TO THROW THEM AWAY OR IF THEY ARE NOT CAUGHT AT THE TIME A POTENTIAL FOR LOSS OF IRRETRIEVABLE TISSUES.