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

Device Problem Chemical Spillage (2894)

Patient Problem Irritation (1941)

Event Date 07/28/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The employees subject of the reported event did not seek medical treatment.They left the area where the reported oil was present.A steris field service technician arrived onsite, inspected the v-pro max sterilizer, and identified the spill was from the oil under the pump.The unit subject of the reported event did not malfunction but rather dripped oil after the user facility relocated the sterilizer.The technician cleaned the pump and performed an oil change to the unit, tested them, and confirmed they were operating according to specification.The technician discussed the proper use and operation of the sterilizer with the user facility staff.

Event Description

The user facility reported that while relocating their v-pro max sterilizer oil dripped out from the unit onto the floor.The oil was cleaned from the floor but three employees became irritated from the smell of the oil.No report of procedural delay or cancellation.

• 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: 5031950
• MDR Text Key: 25116383
• Report Number: 3005899764-2015-00056
• 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
• Report Date: 08/26/2015

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: Not provided
• Initial Date FDA Received: 08/26/2015
• 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