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

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

All instruments affected were reprocessed prior to use in patient procedures.The user facility stated the instrument pack wrap was getting caught within the sterilizer during the unloading process, causing them to rip.A steris service technician arrived on-site, inspected the unit, and confirmed the unit to be operating according to specification.The technician identified user facility personnel were not properly unloading the sterilizer, resulting in the reported event.The v-pro max sterilizer operator manual states the proper unloading practices for the sterilizer in section 6.5.3 on page 6-14.The technician notified the user facility of the proper unloading practices when using the v-pro max sterilizer, specifically how to avoid ripping the wrapping on the instrument packs.No additional issues have been reported.

Event Description

The user facility reported the wrap on their instrument packs were ripping while unloading their v-pro max sterilizer.A procedure delay occurred due to reprocessing of the instrument packs.

• 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6785384
• MDR Text Key: 82665999
• Report Number: 3005899764-2017-00038
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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: 07/12/2017
• 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