MAUDE Adverse Event Report: MEDIVATORS SCOPE BUDDY ENDOSCOPE FLUSHING AID; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number	78399-616
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that their scope buddy unit began emitting flames while the unit was operating.The fire was extinguished and there was no harm.This event could potentially lead to serious injury if it were to recur.Medivators received the power supply of the scope buddy from the user facility for product analysis and testing.Given the current state of the power supply, a root cause cannot be established.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
The user facility reported that their scope buddy unit began emitting flames during a cycle.The fire was extinguished and there was no harm.

• Brand Name: SCOPE BUDDY ENDOSCOPE FLUSHING AID
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 11391993
• Report Number: 2150060-2021-00004
• Device Sequence Number: 11053984
• Product Code: FEB
• UDI-Device Identifier: 00677964063640
• UDI-Public: 00677964063640
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K162128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: 78399-616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other