MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 76" FLOORLOADER STERILIZER

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

Patient Problem Burn, Thermal (2530)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found that user facility personnel were not utilizing a loading cart compatible with the steris sterilizer.The technician also found that the rollers within the sterilizer required replacement due to wear.The technician replaced the rollers and confirmed the sterilizer to be operating properly.The sterilizer was returned to service and no additional issues have been reported.Steris is working with the customer for purchase of new loading carts approved for use with the subject sterilizer.The employee was not wearing gloves during the time of the reported event.The operator manual states (pp.6-1), "warning - burn hazard: sterilizer, rack/shelves, and loading cart 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." following the reported event, the steris technician discussed the importance of utilizing an approved loading cart with the sterilizer, and the importance of wearing ppe.

Event Description

The user facility reported that an employee was removing a loading cart from the sterilizer after a completed cycle when her hand slipped and contacted the inside of the sterilizer.The employee obtained a burn due to her hand contacting the sterilizer's chamber.No medical treatment was sought or administered.

• Brand Name: 76" FLOORLOADER 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: 7346015
• MDR Text Key: 102793592
• Report Number: 3005899764-2018-00019
• 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: 03/16/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/16/2018
• 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