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

Device Problem Unintended System Motion (1430)

Patient Problem Burn(s) (1757)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco 400 sterilizer and found that the door would not stay in position once opened.Upon further inspection the technician determined the hinge set screws required adjustments.The technician adjusted the hinge set screws, tested the unit, confirmed it to be operating according to specifications, and returned it to service.The amsco 400 operator manual states (1-2), "warning - burn hazard: sterilizer, rack/shelves will be hot after cycle is run.Always wear protective gloves and apron when removing a processed load.Protective gloves and apron must be worn when reloading sterilizer following the previous operation." no additional issues have been reported.

Event Description

The user facility reported that an employee backed into the open door of their amsco 400 sterilizer following a completed cycle resulting in a burn on their elbow.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 44060 ; 4403927453
• MDR Report Key: 12369757
• MDR Text Key: 268205057
• Report Number: 3005899764-2021-00046
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2013
• 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