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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2014
Event Type  Malfunction  
Manufacturer Narrative

There are no reported injuries associated with this event. Evaluation summary: the reported symptom was initially reproduced; however, during troubleshooting the multimeter probe made contact with resistor r45 creating a spark on the ultrasonic generator (500 w) board, p/n 12008 where as the board began to function as intended. 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. The biomed / facility staff was provided a copy of the technical bulletin - tb-2013-004. The customer was also informed that this procedure should be carried out every morning prior to the processing of any scopes. Given the nature of endoscope pre-processing and high-level disinfection based on sgna 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 noticed that the ultrasonic function was not operating as intended.

 
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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 Key5020865
MDR Text Key24690973
Report Number3007082252-2014-00032
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,USER F
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 11/20/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2015
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/20/2012
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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