MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO 1 PLUS STERILIZER

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Irritation (1941); Dizziness (2194); Reaction (2414)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the reported event, a steris service technician was onsite performing repairs to the printer for the sterilizer subject of the event.The sterilizer was idle and had not run a cycle during the time of the repairs to the printer.The technician opened the door of the sterilizer and at that time the reported event occurred.The technician did not experience any irritation or dizziness when the door was opened.The technician inspected the sterilizer and ran a leak test.No issue with the function of operation of the sterilizer was identified; no repairs were required.User facility personnel stated they have not experienced any irritation with the unit since the subject event.It should be noted that the unit is located in a room with several other pieces of capital equipment that also use various chemistries and chemicals.The technician completed repairs to the printer and returned the unit to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that two employees experienced dizziness and eye irritation while in the room with their v-pro 1 plus sterilizer.No medical treatment was sought or administered and the employees continued working.

• Brand Name: V-PRO 1 PLUS STERILIZER
• Common Device Name: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• MDR Report Key: 10220746
• Report Number: 3005899764-2020-00042
• Device Sequence Number: 15425991
• Product Code: MLR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1