MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 60" CENTURY STERILIZER

Device Problem Sticking (1597)

Patient Problem Injury (2348)

Event Date 04/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived on site, inspected the unit and confirmed it to be operating according to specification.The technician identified that the employee subject of the reported event pulled on a locked door at the conclusion of a cycle, because she believed that the door was stuck, causing a shoulder injury.Medical treatment was sought and administered.The operator manual states in section 5.4 the proper way of unloading and unlocking the sterilizer.The technician notified the user facility of the proper way to unloading and unlocking the sterilizer.The unit is under steris contract for preventative maintenance services.The technician proactively rebuilt the s35 and s37 valves, adjusted the psi, and reinstalled the door seal while on site.No additional issues have been noted with the sterilizer.

Event Description

The user facility reported that an employee strained her shoulder while unlocking the door on their 60" century sterilizer.No procedural delay or cancellation was reported.

• Brand Name: 60" 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: 5633881
• MDR Text Key: 44482675
• Report Number: 3005899764-2016-00035
• 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: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• 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: 04/14/2016
• 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