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

Device Problems Fire (1245); Device Emits Odor (1425)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

Event Type  malfunction  

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 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
• 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: 10487827
• MDR Text Key: 206729881
• Report Number: 3005899764-2020-00053
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• 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