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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tingling (2171); No Code Available (3191)

Event Date 10/01/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that after a completed cycle, an employee was removing an item from a tray and felt a tingling sensation on her fingers.The employee's fingers then turned white.The employee went to the er.The user facility did not provide information regarding treatment that may have occurred when the employee went to the er.No procedural delays or cancellations were reported.

Manufacturer Narrative

A steris service technician inspected the sterilizer and found it to be operating properly; no issues were noted and the reported event was unable to be duplicated.The technician stated that the employee subject of the reported event was not wearing proper ppe, specifically gloves, while removing items.The operator manual states (pp.6-28), "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.

• 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 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 road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4210814
• MDR Text Key: 18922005
• Report Number: 3005899764-2014-00110
• 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: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/29/2014
• 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