MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD; STERILIZER, CHEMICAL

Lot Number 14100-004

Device Problems Problem with Sterilization (1596); Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

Patient Problem No Information (3190)

Event Date 11/02/2015

Event Type  malfunction  

Event Description

A clean/non-sterile scope was used during the operation.

• Brand Name: STERRAD
• Type of Device: STERILIZER, CHEMICAL
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology dr.; irvine CA 92618
• MDR Report Key: 5385106
• MDR Text Key: 36615442
• Report Number: 5385106
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 14100-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2015
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR