MAUDE Adverse Event Report: MEDIVATORS INC. DSD EDGE ENDOSCOPE REPROCESSING SYSTEM; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number DSD EDGE 120V

Device Problems Fire (1245); Smoking (1585)

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

Event Date 08/23/2021

Event Type  malfunction  

Event Description

Black smoke appeared from back of medivator dsd edge located in endoscopy lab decontamination room.Staff called out for help.Co-worker then attempted to cut power to machine from wall circuit.Machine continued to smoke and grow larger, but co-worker was too short to reach back to unplug machine from wall.Another staff member reported to room jumped on counter reached behind machine and pulled electrical cord out of machine/unplugged from machine (still connected to wall).Smoke/flames/sparks slowed stopped and team cleared out area and ventilated space.Risk alert: ground fault interrupter (gfi) located in machine was directly under hose (plastic) containing liquid chemical.Hose failed, fluid expelled onto internal outlet and caused electrical fire.All dsd edge machines in the ministry need to be assessed for the presence of a cover over this internal outlet to prevent fire/risk of fire!!!!!.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 12404576
• MDR Text Key: 269293390
• Report Number: 12404576
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD EDGE 120V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1