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

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event.During his inspection the technician observed sparks coming from the wiring connected to the heating elements.The technician was not injured.The technician found that the wiring that connects to the heating elements was loose allowing the unit to short.Because of the loose connection of the electrical wiring to the heating element, the temperature of the unit was unable to fully heat up resulting in the reported alarm.The heat generated from the shortage caused the shield that covers the internal components of the wire to melt.The technician replaced the wire and heating elements, ran a test cycle, confirmed the unit to be operating according to specifications, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported a low temperature alarm on their evolution sterilizer.

• Brand Name: EVOLUTION STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8219818
• MDR Text Key: 132578363
• Report Number: 3005899764-2019-00001
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• 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: 12/05/2018
• 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