MAUDE Adverse Event Report: MEDIVATORS INC SCOPE BUDDY PLUS ENDOSCOPE FLUSHING AID

Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via user facility medwatch report # mw5148599 that the one way valve to their scope buddy plus endoscope flushing aid is not operating properly and allowing water to pass through to the detergent bottle.No report of injury.
Additional Manufacturer Narrative
The investigation into the reported event is in process; a follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the event was returned to medivators for evaluation and found to be operating properly.The reported event could not be duplicated.The scope buddy plus endoscope flushing aid is used during the manual cleaning process.All endoscopes flushed by the scope buddy plus endoscope flushing aid must be subsequently high-level disinfected prior to use in patient procedures.The scope buddy plus endoscope flushing aid operator manual states, "scope buddy plus endoscope flushing aid is designed to facilitate the flushing of rinse water, air and medivators or steris detergent solutions through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing and prior to high-level disinfection or sterilization.After flushing with the scope buddy plus endoscope flushing aid, the endoscope must be high-level disinfected by an approved automated endoscope reprocessor (aer) or manually, according to endoscope manufacturer guidelines, prior to use on a patient.This device is not an endoscope washer/disinfector (reprocessor) and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.Scope buddy plus endoscope flushing aid does not replace an automated endoscope reprocessor (aer)." the user facility received a replacement unit.No additional issues have been reported.

• Brand Name: SCOPE BUDDY PLUS ENDOSCOPE FLUSHING AID
• Common Device Name: ENDOSCOPE FLUSHING AID
• 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 north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18497126
• Report Number: 2150060-2024-00004
• Device Sequence Number: 8145916
• Product Code: FEB
• UDI-Device Identifier: 00677964073755
• UDI-Public: 00677964073755
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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