MAUDE Adverse Event Report: MEDIVATORS, INC. ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM

Model Number 1-2-510.003

Device Problem Break (1069)

Patient Problem Eye Pain (4467)

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the tempered glass lid on the right side of the unit was shattered.While onsite, the technician was informed by user facility personnel that a scope was being processed at the time of the event.The scope had been removed from the unit prior to the technician's arrival onsite.The technician was unable to determine a cause of damage to the lid.The technician replaced the lid, tested the unit, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.

Event Description

The user facility reported that the advantage plus endoscope reprocessing system unit was running a cycle when the lid shattered.An employee was sprayed with liquid as they attempted to turn the unit off.The employee reported their eyes were burning and sought medical treatment at the er.The user facility did not disclose if medical treatment was sought or administered.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Type of Device: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 15278051
• MDR Text Key: 303232582
• Report Number: 2150060-2022-00033
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• 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: 08/23/2022

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
• Device Operator: Health Professional
• Device Model Number: 1-2-510.003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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