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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOM ULTRASONICS SYSTEM 83 PLUS 9; ACCESSORIES, CLEANING, FOR ENDOSCOPE
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CUSTOM ULTRASONICS SYSTEM 83 PLUS 9; ACCESSORIES, CLEANING, FOR ENDOSCOPE Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944)
Patient Problem Fungal Infection (2419)
Event Date 03/07/2014
Event Type  malfunction  
Event Description
Patient's colonscopy was done with a colonoscope of unknown status of disinfection.Random cultures of three colonoscopes were taken and reported as positive for fungus two days later.It is unknown whether this patient's colonoscope was one of the three, as they were reportedly returned to service prior to knowing the culture results.The system 83 plus 9 washer-disinfectors in use have been cultured, and the results are pending.The 5.0 micron sediment pre-filter was changed out with reportedly blackened sediment-appearing debris in it.These filters are usually changed every 3 months, and this was the first time we have seen this.It is our belief that this occurred as a result of not adequately flushing the water supply when the heat exchanger was repaired two weeks ago.The tubing leading from the hospital water source to the system 83 plus 9 washer-disinfectors has since been changed.
 
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Brand Name
SYSTEM 83 PLUS 9
Type of Device
ACCESSORIES, CLEANING, FOR ENDOSCOPE
Manufacturer (Section D)
CUSTOM ULTRASONICS
144 railroad drive
ivyland PA 18974
MDR Report Key3753222
MDR Text Key15362867
Report Number3753222
Device Sequence Number1
Product Code FEB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/11/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2014
Event Location Hospital
Date Report to Manufacturer04/16/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/11/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COLONOSCPOPE. CU 5 MICRON WATER PREFILTER; NO OTHER THERAPIES
Patient Age84 YR
Patient Weight56
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