MAUDE Adverse Event Report: STERIS CORPORATION - HOPKINS STERIS SYSTEM 1E; LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 10/12/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician inspected the system 1e and found it to be operating properly.No issues were noted and the processor was returned to service.No additional issues have been reported.The steris service technician reviewed the cycle printout subject of the reported event and confirmed the processing cycle completed without any issues.The technician also reviewed the user facility's processing log for the system 1e.The log verified that the s40 cup was empty after the completed cycle and that the indicator evidenced passing results.The operator manual states (pp.1-3), "appropriate personal protective equipment (ppe) is required when handling containers of s40 sterilant concentrate.Minimally, ppe should consist of chemical-resistant gloves, apron, goggles or face shield, and any other protection required by facility procedures.".

Event Description

The user facility reported that an employee came in contact with s40 sterilant concentrate and obtained a burn.The employee stated that there was a hole in her glove and thought "acid" got on her finger causing a burn.The employee self administered isopropyl alcohol and was then directed to the facility's wellness center; the facility's wellness center then contacted (b)(4).The employee could not confirm when or how she obtained the burn.

• Brand Name: STERIS SYSTEM 1E
• Type of Device: LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5214687
• MDR Text Key: 30968405
• Report Number: 3000251274-2015-00042
• Device Sequence Number: 1
• Product Code: MED
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• 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?: Yes
• Date Manufacturer Received: 10/12/2015
• 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