MalfunctionFLE
AESCULAP RETENTION PLATE
Received Jun 21, 2023
Report MW5118703 · MDR key 17185986
Device
Product problems
- Flaked
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PRODUCT: RETENTION PLATES FROM AESCULAP, PRODUCT NUMBER JK100 ARE LEAVING BLACK FLECKS INSIDE OF SURGICAL TRAYS THAT ARE STERILIZED. BLACK FLECKS AND RETENTION PLATES WAS SENT TO AN INDEPENDENT LABORATORY FOR IDENTIFICATION AND ANALYSIS. RESULTS: BLACK FLECKS ARE PLASTIC. PLASTIC BLACK FLECKS AND PLASTIC ON RETENTION PLATE ARE OF SIMILAR COMPOSITION. LAB RESULTS ARE AVAILABLE UPON REQUEST.