MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. EAGLE 3000 STAGE 3 STERILIZER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Injury (2348); Burn, Thermal (2530)

Event Date 10/24/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived at the facility following the event, and was informed that the employee attempted to open the sterilizer door following a morning dart cycle; however, the employee was unable to open the door even by using excess force.The employee returned several hours later and again attempted to open the door.The employee stated that "more force than usual" was used to open the door upon which time steam escaped from the door chamber.The steris service technician inspected the sterilizer and found a broken component on the door lock diaphragm.The technician replaced the door lock diaphragm, door lock thrust washer, and door lock assembly, tested the unit and returned it to service.The sterilizer was installed in august of 1987 and is currently under a steris service contract.The employee injured in this event informed the steris technician that she thought there could be steam pressure inside of the sterilizer chamber due to the amount of force that was used to open the door; however, the employee continued to turn the wheel until the door was opened.The steris technician informed the employee to contact steris for sterilizer inspection or repairs if the door is not operating as expected.The eagle 3000 stage 3 sterilizer operator manual states, "burn and shock hazard: repairs and adjustments should be attempted only by authorized persons fully acquainted with this equipment.Use of inexperienced, unqualified persons to work on the equipment or the installation of unauthorized parts could cause personal injury or result in costly damage!" no further issues have been reported.

Event Description

The user facility contacted steris to report an employee was injured when steam escaped the sterilizer chamber upon opening the sterilizer door.The employee resumed working activities following the reported injury.No procedure delays or cancellations were reported.

• Brand Name: EAGLE 3000 STAGE 3 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6113033
• MDR Text Key: 60795827
• Report Number: 3005899764-2016-00083
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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: 10/24/2016
• 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
• Patient Outcome(s): Other