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

Model Number 1-2-510.003

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  malfunction  

Event Description

The user facility reported that white residue was observed on a scope that was used during a patient procedure.The scope was processed in their advantage plus endoscope reprocessing system prior to use.No report of injury or procedure delay.

Manufacturer Narrative

Through follow-up with user facility personnel, it was noted that the white residue was also observed in the patient's colon.No medical intervention was required.Facility personnel informed the technician that rapicide pa high-level disinfectant was used to disinfect the scope subject of the reported event and that a strong smell was noted.The technician was also informed that an employee's hands "turned white" as she was not wearing proper ppe when handling the scope.No injury was reported.The user manual states, (85) "warning: avoid possible chemical burns.Always wear personal protective equipment (gloves, goggles) when handling disinfectant and/or detergent." a steris service technician arrived onsite to inspect the advantage plus endoscope reprocessing system.The technician ran 4 test cycles and could not duplicate the reported issue.No issues were noted with the function or operation of the reprocessing system, and it was returned to service.The reported event may be attributed to user error as user facility personnel should have ensured that all hookup connections were properly made in addition to ensuring that the scope was properly disinfected prior to procedural use.The advantage plus endoscope reprocessing system user manual states (68), "before closing the basin lid, inspect the hookup to ensure that all connections are made properly, and the tubing does not interfere with the sprayer." the user manual further states (80), "before removing the endoscope, verify all connections to the endoscope are secure.If an adapter is loose or disconnected, the disinfection was not complete and must be repeated.Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient.If there is any doubt as to whether an endoscope is correctly disinfected, it must be disinfected again before use." the user manual further states (14), "the efficacy of a disinfection procedure is directly related to the disinfectant solution used, and the amount of time the endoscope is exposed to that solution.Rapicide¿ pa high-level disinfectant must be monitored for potency every reprocessing cycle according to the instructions in this manual.Use the rapicide¿ pa test strips to test the potency of the solution.If the potency of the solution is below mrc minimum recommended concentration (mrc), discard and replace it with fresh solution.Never use disinfectant with unacceptable potency levels." steris has offered in-service training on the proper use and operation of the advantage plus endoscope reprocessing system; however, a date is in the process of being scheduled.A 3-year complaint review indicates this to be an isolated event.A follow-up mdr will be submitted when additional information becomes available.

Manufacturer Narrative

Steris completed in-service training on the proper use and operation of the advantage plus endoscope reprocessing system, specifically on the importance of ensuring all hookup connections are properly made prior to use as well as ensuring scopes are properly disinfected prior to procedural use.No additional issues have been reported.

• 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: 16026080
• MDR Text Key: 305950141
• Report Number: 2150060-2022-00051
• Device Sequence Number: 1
• Product Code: FEB
• 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,Followup
• Report Date: 12/21/2022

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
• Device Model Number: 1-2-510.003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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