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

Device Problem Insufficient Information (3190)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

All instruments were reprocessed prior to use in procedures.A steris service technician arrived onsite following the reported event.The technician inspected the unit and found it to be operating according to specification; no repairs were required.The technician inspected the cycle printout for the load subject of the reported event and noted a "load test repeated" message printed on the cycle tape.The "load test repeated" message occurred due to the sterilizer detecting moisture on the instrument pack, potentially due to being placed in the wet working area, prior to being placed into the sterilizer.The v-pro max operator manual, (a-1) states, "dry all items thoroughly.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion and/or a cycle abort occurs.Only dry items are to be placed in sterilization unit." the employee handling the instrument pack observed moisture and proceeded to touch the pack with their bare hand resulting in a burn.The technician confirmed the injured employee was not wearing proper ppe, specifically chemical-resistant gloves, while unloading the sterilizer as stated in the unit's operator manual.The v-pro max operator manual (1-2) states, "(b)(4), 2013, recommends using chemical-resistant gloves when using the sterilization unit." a steris account manager provided in-service training on the importance of wearing proper ppe, specially gloves while operating their v-pro max sterilizer.No additional issues have been reported.

Event Description

The user facility reported that an employee experienced a burn while unloading their v-pro max sterilizer.No procedure delay or cancellation occurred.The employee washed their hands with soap and water for approximately 20 minutes and returned back to work.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7307809
• MDR Text Key: 101520260
• Report Number: 3005899764-2018-00014
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• 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