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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Dizziness (2194); Reaction (2414)

Event Date 06/02/2020

Event Type  malfunction  

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 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
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 10220746
• MDR Text Key: 197756362
• Report Number: 3005899764-2020-00042
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 07/01/2020
• 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