MAUDE Adverse Event Report: STERIS CORPORATION VALSURE ENZYMATIC CLEANER

Device Problem Device Reprocessing Problem (1091)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/24/2014

Event Type  No Answer Provided  

Event Description

A customer contacted steris in concern of a bronchoscope that was not properly cleaned using valsure enzymatic cleaner.

Manufacturer Narrative

Steris quality spoke with the user facility's director of surgery who stated that a bronchoscope was used on a patient, removed and placed on a cart for reprocessing.The top of the scope was immersed in the valsure cleaner.The scope was then removed from the cleaner, rinsed, and reused on the patient.No cleaner was flushed through the scope, only the top was immersed.The patient was prescribed an antibiotic and has no adverse effects.The steris account manager will offer in-service training on the proper use of valsure cleaner.

Manufacturer Narrative

The steris account manager offered in-service training; however, the user facility declined.

• Brand Name: VALSURE ENZYMATIC CLEANER
• Type of Device: CLEANER
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3829564
• MDR Text Key: 4497121
• Report Number: 1937531-2014-00004
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other