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

Model Number 78399-616

Device Problem Fire (1245)

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

Event Date 01/29/2021

Event Type  malfunction  

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 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
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: mitchell cole ; 9800 59th ave n; plymouth, MN 55442 ; 7638984338
• MDR Report Key: 11391993
• MDR Text Key: 233975406
• Report Number: 2150060-2021-00004
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063640
• UDI-Public: 00677964063640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• 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
• Device Operator: Health Professional
• Device Model Number: 78399-616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2009
• 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
• Patient Outcome(s): Other