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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 08/12/2015
Event Type  Malfunction  
Manufacturer Narrative

There are no reported injuries associated with this event. The reported symptom was attributed to a failed transducer crystal/nose and tail pc assembly, p/n 12061, and was likely caused by liquid ingress that created a shorting condition to the transducer wire. The returned ultrasonic generator (500 w) board, p/n 12008, date code jan. 11, 2011, was found to perform as intended.

 
Event Description

During a site visit to install a ufas, the service technician noticed 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 Key5050939
MDR Text Key25508932
Report Number3007082252-2015-00010
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/12/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/02/2015
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 Received08/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2011
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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