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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fungus (1872); Infection, Indirect (2245)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators received medwatch report mw5083990, in which a facility reported three patients with positive fungal (exophiala) cultures following bronchoscopy procedures.The facility listed their dsd edge automated endoscope reprocessor (aer) on the report in connection to this event.Medivators was not informed of this event directly from the facility.Medivators field service engineers (fse) have visited the facility around the same time the event occurred and the facility did not mention anything related to this event.Additionally, an fse indicated that the two aers installed on site were in poor condition and were repaired and returned to service at each visit.On the medwatch report, the facility reported that the device was returned to the manufacturer but medivators has not received the device.The chemistry used with the dsd edge is rapicide pa high level disinfectant (hld).When used per the instructions for use, rapicide pa is effective against fungal organisms such as exophiala.Medivators ra has made multiple attempts to contact the facility for further information regarding the reported event and the current condition of the patients.The cause of the reported positive fungal cultures is unknown.Limited information was provided on the medwatch report.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
Medivators received medwatch report mw5083990, in which a facility reported three patients with positive fungal (exophiala) cultures following bronchoscopy procedures.The facility listed their dsd edge automated endoscope reprocessor (aer) on the report in connection to this event.Medivators was not informed of this event directly from the facility.

• Brand Name: DSD EDGE
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8458208
• Report Number: 2150060-2019-00024
• Device Sequence Number: 18918477
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: Other
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/27/2019
• 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