MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS EVOTECH; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number EVOTECH

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/09/2020

Event Type  malfunction  

Event Description

Technician found small black particles in the zenpure pureflow z series 0.2 micron filter.

• Brand Name: EVOTECH
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 10477096
• MDR Text Key: 205153075
• Report Number: 10477096
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EVOTECH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1