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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Sprain (2083)

Event Date 05/09/2018

Event Type  Malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the event to inspect the 48" century sterilizer. The technician tested the functionality of the door and door seal and was unable to duplicate the reported event. The technician replaced the unit's door seal and air solenoid valve as a precautionary measure while onsite. A review of the device history record for the subject sterilizer was reviewed and confirmed that the unit was manufactured in accordance with specification. The technician tested the unit following the repairs and confirmed that the sterilizer was operating according to specification and returned the unit to service. No additional issues with the door unlock function have been reported.

Event Description

The user facility reported that during the use of a 48" century sterilizer, the door would not unlock at the end of a successfully completed cycle. At the end of the cycle, the customer tried to force the door lever to the unlock position and felt pain in their shoulder. The employee sought medical treatment for the reported shoulder pain and was diagnosed with a sprain.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7579188
• MDR Text Key: 110723955
• Report Number: 3005899764-2018-00040
• 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: 06/07/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/07/2018
• 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
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/10/2018
• 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