MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 20" EAGLE 3000 STERILIZER STG 3

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 10/19/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The employee had unlocked the sterilizer door and walked away.Approximately 15 minutes after the employee unlocked the sterilizer door his arm began to swell.A steris service technician arrived onsite however, the user facility would not allow the technician to inspect the sterilizer.As the steris technician was unable to inspect the sterilizer it can not be determined if the sterilizer was the cause of the reported event.The operator manual states (pp.2-6), "a handwheel operates the manual door for locking or unlocking.Door can be swung open or closed from the unlocked position.To open door from locked position-rotate handwheel counterclockwise as far as it will go using normal hand pressure and swing door open by hand." the technician advised the employee to stretch his forearms prior to unlocking the sterilizer door.The sterilizer was remanufactured in 2001 and is serviced and maintained by the user facility.

Event Description

The user facility reported that after an employee unlocked the sterilizer door, their arm became swollen.The employee sought medical treatment.

• Brand Name: 20" EAGLE 3000 STERILIZER STG 3
• 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: 5233546
• MDR Text Key: 31526748
• Report Number: 3005899764-2015-00076
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• 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: 10/21/2015
• Was Device Evaluated by Manufacturer?: No
• 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