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

Device Problem Smoking (1585)

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

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the sterilizer.Contrary to the reported event, the "smoke" observed by user facility personnel was actually an oil mist.The technician found that one of the vacuum pump clamps had detached causing oil mist to fill the room with a "haze".The technician reattached the clamp, tested the unit, confirmed it to be operating according to specification, and returned it to service.A district service manager retrained the technician on proper maintenance activities for the v-pro 1 plus sterilizer.No additional issues have been reported.

Event Description

The user facility reported that their v-pro 1 plus sterilizer was emitting smoke.No report of injury.No evacuation was required.

• Brand Name: V-PRO 1 PLUS 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: 8181137
• MDR Text Key: 131035685
• Report Number: 3005899764-2018-00113
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• 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: 12/04/2018
• 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
• Patient Sequence Number: 1