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

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A technician from steris dealer, device technologies australia (dta), arrived onsite to inspect the unit and found that fittings on the reservoir required replacement.The damage to the fittings allowed sterilant to leak from the reservoir onto electronic components below causing the electrical wires to short and the reported event to occur.The technician performed the necessary repairs, tested the unit, confirmed it to be operating to specification, and returned it to service.The unit was manufactured in 2011 making it approximately 9 years old.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 their v-pro 1 plus sterilizer had successfully completed a cycle when user facility personnel noticed a burning smell and observed flames coming from the unit.The fire was extinguished by a user facility employee.No report of injury.

• 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: 10487827
• Report Number: 3005899764-2020-00053
• Device Sequence Number: 3663144
• Product Code: MLR
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1