MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO 1 STERILIZER

Device Problem Chemical Problem (2893)

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

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found that the two ports for the oil return line were closed causing the oil filters to deteriorate.The technician observed that the oil filters were saturated with oil and oil residue.The technician performed an oil change, repaired the unit, ran a test cycle, and returned the unit to service.No additional issues have been reported.The last pm was performed in (b)(6) 2017 and the technician confirmed the sterilizer was operating within specifications and no odor was detected.

Event Description

The user facility reported an oil mist emitting from their v-pro 1 sterilizer.No report of injury or irritation.

• Brand Name: V-PRO 1 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: 6576992
• MDR Text Key: 75663666
• Report Number: 3005899764-2017-00021
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/18/2017
• 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