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

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

All instruments subject of the reported event were reprocessed prior to use.A steris service technician arrived onsite following the reported event to inspect the sterilizer and found that the solid state relay was damaged.The solid state relay is an electrical switch located in a box on the side of the unit.The technician replaced the solid state relay, tested the sterilizer, and found the unit to be operating according to specification.The sterilizer was returned to service.The eagle sterilizer was installed in 2001 making the unit approximately 17 years old and is not under steris service agreement for maintenance activities.A 3-year complaint review indicates this to be an isolated event and no additional issues have been reported.

Event Description

The user facility reported that their eagle sterilizer began to smoke.No report of injury or inhalation/irritation.

• Brand Name: EAGLE 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: 8139386
• MDR Text Key: 129622991
• Report Number: 3005899764-2018-00106
• Device Sequence Number: 1
• Product Code: FLE
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• 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: 11/15/2018
• 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