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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS SSD-102; AUTOMATED ENDOSCOPE REPROCESSOR

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MEDIVATORS SSD-102; AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
Device Problems Residue After Decontamination (2325); No Apparent Adverse Event (3189)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2018
Event Type  Injury  
Manufacturer Narrative
The facility reported their ssd 102 automated endoscope reprocessor (aer) had blue droplets left in the basin after the reprocessing and air purge cycles.There is potential risk for high level disinfectant residuals left in the endoscope thus potential chemical colitis.A medivators field service engineer (fse) confirmed the ssd 201 aer was investigated and the tubing and reservoirs of the machine have been replaced.The chemistry of the machine was switched from cidex opa28 to rapicide opa28.The medivators fse stated the facility was experiencing hard water issues and recently installed a water softener.The water was tested within specification by medivators fse.The fse ran test cycles on the aer and all cycles were within specification.The facility recently confirmed the endoscopes are not leaking blue residue into the basin after they switched to rapicide opa28.This will continue to be monitored on the medivators complaint system.
 
Event Description
The facility reported their ssd 102 automated endoscope reprocessor (aer) had blue droplets left in the basin after the reprocessing and air purge cycles.There is potential risk for high level disinfectant residuals left in the endoscope thus potential chemical colitis.
 
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Brand Name
SSD-102
Type of Device
AUTOMATED ENDOSCOPE REPROCESSOR
Manufacturer (Section D)
MEDIVATORS
14605 28th ave n
plymouth MN 55447
Manufacturer (Section G)
MEDIVATORS
14605 28th ave n
plymouth MN 55447
Manufacturer Contact
lauren johnson
14605 28th ave n
plymouth, MN 55447
MDR Report Key7899931
MDR Text Key121438424
Report Number2150060-2018-00065
Device Sequence Number1
Product Code FEB
UDI-Device Identifier00677964035647
UDI-Public00677964035647
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 company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/21/2018
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/23/2018
Initial Date FDA Received09/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2012
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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