MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 48" CENTURY STERILIZER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 12/16/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The employee stated that the sterilizer's door lever was difficult to slide when unlocking the door.During this sequence the employee felt pain in her shoulder.A steris service technician inspected the sterilizer door and removed the door handle and cover plate.The technician removed and cleaned the bearings that rotate in the coupler plate lock and re-installed.The technician also adjusted the thumbscrews that are located in the spring plate retainers (upper and lower).The sterilizer was tested and returned to service.No additional issues have been reported.While onsite the technician discussed with facility personnel the proper use and operation of the sterilizer.

Event Description

The user facility reported that an employee injured their shoulder when opening the door on their 48" century sterilizer after a completed cycle.The employee sought medical treatment and was given a pain reliever.

• Brand Name: 48" CENTURY 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: 5357991
• MDR Text Key: 35997178
• Report Number: 3005899764-2016-00003
• 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: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• 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: 12/16/2015
• 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