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

Device Problem Fire (1245)

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

Event Date 12/17/2020

Event Type  No Answer Provided  

Event Description

Fire: endoscopy buddy scope.Shortly after the tech.Was cleaning the scope - an area to the right side of the sink burst into flames.Code red - fire extinguished.No harm.Biomed cleared device for use.Cord not to be used again.Engineering evaluating electrical outlets.Biomed follow up: customer reported an issue with device power supply.Inspected device and tested the electrical safety.Found no issues.Verified proper operation - returned to service.No patient impact.

• Brand Name: SCOPE BUDDY
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 11138947
• MDR Text Key: 225748994
• Report Number: 11138947
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/18/2020

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1