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

Model Number SBP-1000

Device Problem Smoking (1585)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that their scope buddy plus endoscope flushing aid began emitting smoke during a cycle and subsequently shut off.There was no report of user or patient harm.The scope buddy plus was returned to medivators for investigation.Following analysis, no root cause could be established.A two year complaint review was performed and it was confirmed this is an isolated report.Medivators will continue to monitor for similar events to ensure that the product continues to perform as expected.

Event Description

The user facility reported that their scope buddy plus endoscope flushing aid began emitting smoke during a cycle and subsequently shut off.There was no report of user or patient harm.

• Brand Name: SCOPE BUDDY PLUS 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: 12021387
• MDR Text Key: 257107502
• Report Number: 2150060-2021-00009
• 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
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SBP-1000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2021
• 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