MAUDE Adverse Event Report: MEDIVATORS, INC. SCOPE BUDDY PLUS; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number PSFPS-01

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Calibration Problem (2890); Unexpected Shutdown (4019)

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

Event Type  malfunction  

Event Description

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
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS, INC.
• MDR Report Key: 15834465
• MDR Text Key: 304121493
• Report Number: MW5113390
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/16/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSFPS-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1