MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 16" CENTURY STERILIZER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/10/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A review of the service history for the unit shows that maintenance was last performed in 2007.Steris followed up with the user facility contact provided on medwatch (b)(4).The contact person indicated that the unit subject of the reported event has been removed from service.Therefore steris is unable to inspect the unit to determine the root cause of the reported event.A follow-up report will be submitted should additional information become available.

Event Description

The user facility reported via medwatch (b)(4) that their eagle century sterilizer yielded multiple failed bis.No report of injury or procedural delay or cancellation.

Manufacturer Narrative

Steris performed additional follow up with the medwatch contact.The reported event of the failed bi occurred in (b)(6) 2015; the sterilizer was removed from service by user facility personnel.The instruments which were present in the cycle with failed bis were not reprocessed and were used in patient procedures.The user facility followed their protocol to notify patients involved in surgical procedures.

• Brand Name: 16" 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: 5474135
• MDR Text Key: 39759255
• Report Number: 3005899764-2016-00013
• 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: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• 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