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

Device Problem Insufficient Information (3190)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Steris became aware of this event on december 21, 2022 through our periodic review of the maude database.The report did not identify the name or location of the user facility of the device in question.To date we have not been informed of this event directly from the user facility.Should we obtain additional information regarding the user facility or specific device subject of this event, a follow-up report would be filed with the results of our investigation.

Event Description

The user facility reported via user facility maude report (mw5113390) the following, "medical equipment (scope buddy plus) with significant failures used in endoscope reprocessing.First brand new (2) units received were defective (would not power on) and had to be sent back to company for repair.Four additional scope buddy plus machines; one would constantly lose calibration, one would constantly power off, 2 units with damaged ports.Additional units at cboc encountered screen failure and detergent port broke loose; 4 month lead time on repairs.Fda safety report id # (b)(4).".

• Brand Name: SCOPE BUDDY PLUS ENDOSCOPE FLUSHING AID
• Type of Device: 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 n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 16115907
• MDR Text Key: 308015180
• Report Number: 2150060-2023-00004
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• 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: 01/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/06/2023
• 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