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U.S. Department of Health and Human Services

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

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MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
Device Problems Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2018
Event Type  Injury  
Manufacturer Narrative
The facility reported a tan, granular substance remained in the basin of their dsd edge automated endoscope reprocessor (aer) after reprocessing an endoscope.There is potential for patient exposure to the unknown substance during endoscopic procedures.Communication between the facility's biomed and medivators field service engineers determined that the endoscope may not have been properly manually cleaned before being placed in the aer.After reprocessing the endoscope in the aer and noticing the substance, the facility reprocessed it again in a different aer only to find the same substance remaining in that aer as well.The facility reported after running 10 cycles in the second aer, the substance was gone.Medivators field service engineers evaluated the first aer and the facility's biomed technician performed a full preventative maintenance service after dissassembling the unit and thoroughly flushing and scrubbing the affected components.The unit has been removed from service while the facility continues to run cycles and try to clear out the substance.The facility has since purchased a new advantage plus aer to replace the affected dsd edge.The identification of the substance remains unknown.It is unknown if the endoscope has been used in patient procedures since being reprocessed.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.
 
Event Description
A facility reported a tan, granular substance remained in the basin of their dsd edge automated endoscope reprocessor after reprocessing an endoscope.There is potential for patient exposure to the unknown substance during endoscopic procedures.
 
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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 Key8133379
MDR Text Key129341384
Report Number2150060-2018-00072
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 company representative,user f
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 12/05/2018
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
Initial Date Manufacturer Received 11/05/2018
Initial Date FDA Received12/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2011
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;
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