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

Medical Device Problem Codes	Contamination (1120); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility reported a black substance appeared in both basins of their dsd edge automated endoscope re-processor (aer) after completion of a reprocessing cycle.There is potential for patient exposure to the black substance during endoscopy procedures.Medivators field service engineer (fse) evaluated the aer and performed a preventative maintenance (pm) service as requested by the facility.It was determined that the source of the black substance was due to degradation of the disinfectant pumps from extended exposure to the high-level disinfectant.Medivators recommends replacing these pumps at least annually as part of routine preventative maintenance.The facility's biomedical technician reported he was unaware when the last pm was performed on the aer.The facility does not have a service contract with medivators and the aer is normally serviced by the facility's biomedical technicians.Per medivators dsd edge user manual, it is the responsibility of the facility to ensure proper servicing is performed on the aer.The facility reported that their biomedical technicians will perform pm services on the aer in the future.It is unknown if the endoscopes potentially exposed to the black substance were used in patient procedures.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
A facility reported a black substance appeared in both basins of their dsd edge automated endoscope re-processor (aer) after completion of a reprocessing cycle.There is potential for patient exposure to the black substance during endoscopy procedures.

• Brand Name: DSD EDGE
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8387951
• Report Number: 2150060-2019-00021
• Device Sequence Number: 16704841
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other