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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The unit is not serviced or maintained by steris.  a steris service technician and account manager are conducting an investigation in conjunction with the user facility's maintenance personnel.  a follow up report will be submitted once additional information becomes available.

Event Description

The user facility reported their amsco c sterilizer was not operating properly.No injury, procedure delay, or cancellation was reported.

Manufacturer Narrative

The user facility reported their amsco sterilizer overheated emitting a burning odor.A steris account manager was dispatched to the user facility to obtain additional information regarding the reported event.The account manager identified that the user facility removed the amsco sterilizer from service.The user facility services and maintains the sterilizer and declined to disclose additional details regarding the reported event; the user facility did not release the unit for further evaluation by steris.The amsco sterilizer was replaced.No additional issues have been reported by the user facility.

• Brand Name: AMSCO C 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: 6178846
• MDR Text Key: 62698016
• Report Number: 3005899764-2016-00088
• 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,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• 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