MalfunctionFLE

RETENTION PLATE

Received Nov 1, 2023 · Event occurred Oct 9, 2023

Report MW5147663 · MDR key 18059433

Device

Generic name

Sterilizer, Steam

Manufacturer

Aesculap, Inc.

Model number

JK100

Patient

Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

THE RETENTION PLATES FROM AESCULAP, PRODUCT NUMBER JK100 ARE LEAVING BLACK PARTICLES INSIDE OF STERILE SURGICAL TRAY. THE PROBLEM HAS OCCURRED MULTIPLE TIMES.