MAUDE Adverse Event Report: STERIS CANADA ULC STERIS RELIANCE 6000 ; UNIT, DRYING

Model Number RECT1CON20

Device Problems Break (1069); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2020

Event Type  malfunction  

Event Description

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).

• Brand Name: STERIS RELIANCE 6000
• Type of Device: UNIT, DRYING
• Manufacturer (Section D): STERIS CANADA ULC; columbus OH 43228
• MDR Report Key: 9592545
• MDR Text Key: 175480370
• Report Number: MW5092247
• Device Sequence Number: 1
• Product Code: JRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RECT1CON20
• Device Catalogue Number: RECT1CON20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1