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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

No procedural delay or cancellation was reported.A steris service technician arrived on site, inspected the unit, and confirmed the sterilizer to be operating according to specification.The technician identified that when closing the door, the employee subject of the reported event was not lining up the door seal with the appropriate grooves in order to close the door appropriately.When the user facility employee continued to push on the door to try to force the door to close, she injured her wrist.The unit is under steris contract for preventative maintenance services.Although there were no issues identified with the door seal, at the user facilities request, the technician proactively replaced the door seal on the sterilizer.While on-site the steris technician met with the user facility employee subject of the reported event and discussed the proper use and operation of the sterilizer.

Event Description

The user facility reported that an employee was trying to close the door on their medium evolution sterilizer and injured her wrist.No medical treatment was sought and administered.

• Brand Name: MEDIUM EVOLUTION 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: 5706892
• MDR Text Key: 46824076
• Report Number: 3005899764-2016-00040
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• 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: 05/11/2016
• 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