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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fungus (1872); Infection, Indirect (2245)

Event Date 02/25/2019

Event Type  Injury  

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 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
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: hannah shrader ; 14605 28th ave n; minneapolis, MN 55447 ; 7635596863
• MDR Report Key: 8458208
• MDR Text Key: 140119048
• Report Number: 2150060-2019-00024
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2011
• 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