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

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 06/03/2014

Event Type  No Answer Provided  

Event Description

The employee has returned to work and is fine with no sustaining injuries.

Event Description

The user facility reported that after a completed cycle an employee was removing an instrument pack and felt a burning sensation on her fingers.The employee sought medical treatment at employee health where bandages were applied.The employee remains off of work.No procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived onsite and reviewed the cycle printout subject of the reported event.The cycle printout confirmed the cycle completed successfully with no alarms or aborts.In addition, the indicator present in the load evidenced passing results.The technician noted the cycle printout included a message which read "load test repeated".This message suggests that moisture is present in the load.The technician inspected the unit and found it to be operating properly; no issues were noted.The employee was not wearing proper ppe during the time of the reported event, specifically gloves.The operator manual states (99.1-3), "failure to thoroughly clean, rinse and dry articles to be sterilized could result in an ineffective sterilization cycle." the operator manual states (pp.6-29), "unload sterilization unit- steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical-resistant gloves when using the sterilization unit." while onsite the technician discussed the importance of wearing proper ppe and the proper use and operation of the sterilizer.

• 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 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790,; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley rd.; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3959950
• MDR Text Key: 16993360
• Report Number: 3005899764-2014-00052
• 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,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2014
• 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
• Patient Outcome(s): Other