MalfunctionJRJ
STERIS RELIANCE 6000
Received Jan 14, 2020 · Event occurred Jan 2, 2020
Report MW5092247 · MDR key 9592545
Device
Product problems
- Break
- Melted
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
STERIS RELIANCE 6000 ENDOSCOPE DRYING CABINET TUBING SETS STERILIZED FOLLOWING THE IFU FROM THE MFR BECAME MELTED WITH SMALL PIECES OF HARD CLEAR PLASTIC BREAKING OFF AND PRESENT THROUGHOUT THE TUBING AFTER STERILIZING. FDA SAFETY REPORT ID# (B)(4).