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

Model Number	V-PRO MAX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	10/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a burn on their arm after handing a wrap that was previously processed item in their v-pro max sterilizer.No medical treatment was administered, and the employee continued working.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the v-pro max sterilizer and found that the vacuum pump of the unit was leaking oil.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.It is unknown at this time if the employee was wearing proper ppe, specifically gloves while operating the v-pro max sterilizer.The v-pro max sterilizer operator manual (1-2) states, "danger - chemical injury hazard: any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions.When handling hydrogen peroxide, wear appropriate personal protective equipment." the v-pro max operator manual (1-2) states, "ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit." additionally, user facility personnel should ensure all instruments are properly dry prior to placement in the v-pro max 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 technician counseled user facility personnel on the proper use and operation of the v-pro max sterilizer, specifically wearing proper ppe and properly drying instruments.No additional issues have been reported.

• Brand Name: AMSCO V-PRO
• Common Device Name: V-PRO MAX
• 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
• MDR Report Key: 20589030
• Report Number: 3005899764-2024-00062
• Device Sequence Number: 8804236
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: (01)00724995206987(11)171025
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: V-PRO MAX
• Device Catalogue Number: VP30002101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown