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

MAUDE Adverse Event Report: MEDIVATORS 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 DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
Device Problems Component Incompatible (1108); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2018
Event Type  Injury  
Manufacturer Narrative
The facility reported they did not perform a waterline disinfection of their dsd edge automated endoscopes reprocessor after replacing a filter inside the machine.Endoscopes were reprocessed and used on patients before the facility performed a waterline disinfection the following day.There is potential these scopes were exposed to environmental contamination from not performing the waterline disinfection after replacing the filter and subsequently introduced to patients during procedures.Medivators field service engineer visited the facility to replace the filters and run a waterline disinfection after the facility reported concerns of not following the proper maintenance procedure.While the fse replaced the filters, he saw that when the facility personnel had replaced one of the filters, they broke one of the filter housing fittings and had replaced it with a non-medivators fitting.The fse informed the facility that non-medivators parts have not been validated for use with the machine and thus should not be used in the aer.He also went over the proper maintenance procedure for properly replacing filters and performing the waterline disinfection as requested by the facility.Medivators regulatory affairs followed up with the facility's director of patient safety & risk and she estimated that 3-5 endoscopes had been reprocessed and used on patients after the facility replaced the filter and did not run the waterline disinfection.To date, there have been no reports of patient harm caused by potential exposure to bacterial contamination.Medivators remains in contact with the facility and this complaint will continue being monitored in medivators complaint handling system.
 
Event Description
The facility reported they did not perform a waterline disinfect for their dsd edge automated endoscopes reprocessor after replacing a filter inside the machine.Endoscopes were reprocessed and used on patients the following day.There is potential these scopes were exposed to contamination from not performing the waterline disinfect after replacing the filter and introduced to patients during procedures.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7325478
MDR Text Key101954115
Report Number2150060-2018-00016
Device Sequence Number1
Product Code FEB
UDI-Device Identifier00677964046674
UDI-Public00677964046674
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K914145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/08/2018
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 No Information
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/07/2018
Initial Date FDA Received03/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2014
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;
-
-