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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 Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2015
Event Type  Malfunction  
Manufacturer Narrative

There are no patient injuries associated with this event. The reported symptom for the returned ultrasonic generator (500 w) board was attributed to a faulty diode, on the ac input signal, within the bridge rectifier, brg1, on the ultrasonic generator (500 w) board, p/n (b)(4), causing the fuse to open, rendering the board inoperable. This diode is located on the ac input plus side of the bridge rectifier and its failure is likely attributed to age (10 years) and an over voltage or over current condition. 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 - (b)(4). 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 pre-use, after the facility biomed completed a repair, it was noticed that the ultrasonics were not functioning while going through a function test of the components.

 
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Brand NameSYSTEM 83 PLUS 2
Type of DeviceENDOSCOPE WASHER DISINFECTOR
Manufacturer (Section D)
CUSTOM ULTRASONICS INC.
144 railroad drive
warminster PA 18974
Manufacturer Contact
elizabeth lazaro
144 railroad drive
ivyland, PA 18974
2153641477
MDR Report Key5097381
MDR Text Key26731016
Report Number3007082252-2015-00012
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 09/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2015
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 Received09/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/16/2003
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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