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

Device Problem Smoking (1585)

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

Event Date 02/03/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The initial report of smoke may be mistaken for oil mist that may emit from the sterilizer that would require a technician to inspect the unit.Employees present in the sterile processing department during the time of the reported event stated their throat and eyes were burning.The user facility did not disclose whether the employees sought or received medical treatment and if any procedural delays or cancellations occurred due to the event.Prior to the reported event a third party service provider who performs maintenance and service on the unit completed preventive maintenance.During this service activity the service provider did not properly perform the preventive maintenance.A steris service technician inspected the sterilizer and found that the oil filter o-ring was not in the proper position and lack of spring tension on the filters.The v-pro unit may emit an oil mist or what appears to be smoke if the oil filters and o-rings are not installed correctly or damaged.The steris technician replaced the oil filter o-ring and set the oil filter spring tension to the proper setting.The sterilizer was tested and returned to service.No additional issues have been reported.The steris service technician advised facility personnel the importance of proper service activity.

Event Description

The user facility reported that their v-pro max sterilizer was emitting smoke.The area was evacuated and the fire department was called.

• Brand Name: V-PRO MAX 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: 5477664
• MDR Text Key: 39844789
• Report Number: 3005899764-2016-00014
• Device Sequence Number: 1
• Product Code: MLR
• 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: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

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