MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number 78400-409

Device Problem Smoking (1585)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

A medivators field service engineer arrived onsite to inspect the dsd edge aer and found several internal components were damaged.The damage observed to the unit is indicative of a short circuit.The user facility elected to permanently remove the unit from service in lieu of repairing.Medivators requested the unit to be returned for evaluation; however, the user facility declined.A replacement dsd edge aer was installed at the user facility.A 1-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that their dsd edge automated endoscope reprocessor (aer) began emitting smoke from the compressor during a cycle.No report of injury.

• Brand Name: DSD EDGE
• 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: daniel davy ; 14605 28th ave n; plymouth, MN 55447 ; 4403927453
• MDR Report Key: 12110220
• MDR Text Key: 259721590
• Report Number: 2150060-2021-00010
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 78400-409
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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