MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

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

Patient Problem Burn, Thermal (2530)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco 400 sterilizer.Based on the technician's discussion with user facility personnel, the root cause of the reported event is attributed to user error.The employee should have stepped back from the sterilizer when opening the door after a cycle.The amsco 400 sterilizer operator manual states (1-2), "warning - burn hazard: steam may be released from the chamber when door is opened.Step back from the sterilizer each time the door is opened to minimize contact with steam vapor." no issue with the function or operation of the sterilizer contributed to the reported event.The sterilizer was returned to service.The technician counseled user facility personnel on the proper use and operation of the amsco 400 sterilizer, specifically stepping back from the sterilizer while opening the door after a cycle.No additional issues have been reported.

Event Description

The user facility reported that an employee opened the door of their amsco 400 sterilizer at the end of a successfully completed cycle and steam vapor contacted their face resulting in a burn.Medical treatment was sought and administered.

• Brand Name: AMSCO 400 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: 10194500
• MDR Text Key: 214793281
• Report Number: 3005899764-2020-00040
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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: 05/29/2020
• 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