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

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported a black substance in the basins of their dsd edge automated endoscope reprocessor (aer) upon completion of a reprocessing cycle.There is potential for patient exposure to the unknown black substance during endoscopy procedures.Medivators regulatory followed up with the facility's biomedical technician who confirmed the issue had been resolved and it was determined to be caused by the facility's water softener.It was reported that immediately after noticing the black substance in all of their aers, the biomedical technician inspected their facility's water softener and noticed the filters needed to be changed.After replacing the filters, it was verified that the black substance no longer appeared in the basins of the aers and everything was operating according to specification.It is unknown if any endoscopes reprocessed in their dsd edge aer were exposed to the black substance or if they were reprocessed again prior to using in patient procedures.After several attempts, medivators regulatory was unable to verify this information with the facility's clinical education department who initially reported the incident.There were no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported a black substance in the basins of their dsd edge automated endoscope reprocessor (aer) upon completion of a reprocessing cycle.There is potential for patient exposure to the unknown black substance during endoscopy procedures.

• Brand Name: DSD EDGE
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 8501780
• MDR Text Key: 141568045
• Report Number: 2150060-2019-00029
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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