MAUDE Adverse Event Report: STERIS CORPORATION STERILIZER EAGLE / CENTURY SERIES

Model Number V-116

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Information (3190)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

Instrument sterilized in main operating room sterilizer no.10.Cycle process on prevac 4 mins, 5 min dry time.Temp was 271 degrees, pressure 33; 3m attest biological test pack ran with the load processed.Package inspected chemical sterigage test passed.Attest biological test pack opened and internal sterigage passed 100% (b)(6) 2015.Biological test ampule incubated for required 3 hours.The test failed (b)(6) 2015.Three add'l attest biological test repeated (b)(6) 2015.All three test failed.Bio-medical notified.

• Brand Name: STERILIZER EAGLE / CENTURY SERIES
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS CORPORATION; 5960 heislay rd; mentor OH 44060
• MDR Report Key: 5347402
• MDR Text Key: 35246488
• Report Number: MW5058906
• Device Sequence Number: 1
• Product Code: FLE
• 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: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V-116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 109