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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 2 ENDOSCOPE WASHER-DISINFECTOR

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CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 2 ENDOSCOPE WASHER-DISINFECTOR Back to Search Results
Device Problems Device Maintenance Issue (1379); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 08/20/2015
Event Type  Malfunction  
Manufacturer Narrative

There are no patient injuries associated with this event. The reported symptom was attributed to a short of q5, q6, and q7, mosfet switches found on the ultrasonic generator (500 w) board, p/n 12008, which caused the fuse to open, rendering the board inoperable. The loss of the ultrasonic generator does not, of and by itself, result in an endoscopic high level disinfection process failure that does not render a microbiologically safe product or present any additional risks for reuse given the nature of the pre-cleaning labeling instructions and high-level disinfection. Given the nature of endoscope pre-processing and high-level disinfection based on (b)(4) guidelines, either the presence or absence of ultrasonics should still result is an endoscope that has had its bioburden reduced to an acceptable level. It is concluded that there is no reasonable likelihood that an endoscope processed in the absence of the ultrasound will present any additional risks.

 
Event Description

During preventive maintenance, it was discovered that the ultrasonics were not functioning.

 
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Brand NameSYSTEM 83 PLUS 2
Type of DeviceENDOSCOPE WASHER-DISINFECTOR
Manufacturer (Section D)
CUSTOM ULTRASONICS INC.
144 railroad drive
ivyland PA 18974
Manufacturer Contact
elizabeth lazaro
144 railroad drive
ivyland, PA 18974
2153641477
MDR Report Key5055768
MDR Text Key25887216
Report Number3007082252-2015-00011
Device Sequence Number1
Product Code FEB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK983017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation SERVICE PERSONNEL
Type of Report Initial
Report Date 08/20/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/20/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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