MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 48" CENTURY STERILIZER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite and was informed by user facility personnel that at the time of the reported event the employee opened the sterilizer door and the bottom panel of their sterilizer had fallen off.The employee was reinstalling the bottom panel and inadvertently contacted the inside of the open sterilizer door resulting in the reported event.The technician inspected the sterilizer and found the magnets that hold the panel in place were no longer making an adequate connection.The vibration of the door being opened by the employee caused the panel to fall.To resolve the issue, the technician replaced the magnets that hold up the bottom panel, reattached the panel and found the unit to be operating according to specifications.The unit was returned to service.The century sterilizer operator manual states (pg.1-1), "warning - burn hazard: sterilizer, rack/shelves, and loading car will be hot after cycle is run." the 48" century sterilizer was manufactured in 2008 making it approximately 12 years old.No additional issues have been reported.

Event Description

The user facility reported that an employee burned their arm on the inside part of the open door for their 48" century sterilizer door after a completed cycle.Medical treatment was sought.

• Brand Name: 48" CENTURY 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: 9828671
• MDR Text Key: 191392779
• Report Number: 3005899764-2020-00013
• 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: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/13/2020
• 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