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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Dizziness (2194)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found the unit to be operating according to specification.No repairs were required, and the unit was returned to service.Upon arrival, the user facility informed the technician that the employee was not wearing proper ppe, specifically protective eyewear at the time of the reported event.The v-pro max sterilizer operator manual states (i), "all personnel involved in the use and maintenance of this equipment must carefully review and comply with the safety precautions and instructions contained in this manual and the vaprox hc sterilant safety data sheet (sds), product label and package insert." the vaprox hc sterilant safety data sheet states (pg.4), "wear protective eyewear." the v-pro max sterilizer operator manual further states (3-2), "steris recommends (in accordance with aami st58, 2013) the room containing the sterilization unit has a ventilation system capable of an air exchange at least 10 times per hour." the technician counseled user facility personnel on wearing proper ppe when operating the v-pro max sterilizer, specifically wearing protective eyewear.No additional issues have been reported.

Event Description

The user facility reported that an employee experienced eye irritation and dizziness while operating their v-pro max sterilizer.The employee flushed their eyes out with water.

• Brand Name: V-PRO MAX 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 44060 ; 4403927453
• MDR Report Key: 12174394
• MDR Text Key: 261774552
• Report Number: 3005899764-2021-00040
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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: 06/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2013
• 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