• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVATORS INC. DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8458208
MDR Text Key140119048
Report Number2150060-2019-00024
Device Sequence Number1
Product Code FEB
UDI-Device Identifier00677964046674
UDI-Public00677964046674
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092387
Number of Events Reported1
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 Received03/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-