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

Device Problem Leak/Splash (1354)

Patient Problem Irritation (1941)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

The vacuum pump oil is non-toxic and not considered hazardous.A steris service technician arrived onsite to inspect the sterilizer and found that one of the o-rings, located on the oil mist eliminator (ome) became dislodged.As the o-ring became dislodged, this allowed for oil to build up around the filter housing and the reported event to occur.The technician replaced the o-ring, tested the unit, confirmed it to be operating according to specification, and returned it to service.Additional investigation determined that a month prior to the reported event, the technician was onsite to perform maintenance activities and did not properly install the o-ring.A steris district service manager retrained the technician on proper maintenance activities for the v-pro max sterilizer, specifically installing the o-ring.No additional issues have been reported.

Event Description

The user facility reported that an employee experienced irritation from oil mist emitting from their v-pro max sterilizer.Medical treatment was sought and administered; the user facility did not disclose what treatment was administered.

• 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, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9088478
• MDR Text Key: 199550062
• Report Number: 3005899764-2019-00079
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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: 08/21/2019
• 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