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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 9 ENDOSCOPE WASHER AND DISINFECTOR

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CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 9 ENDOSCOPE WASHER AND DISINFECTOR Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2015
Event Type  Malfunction  
Manufacturer Narrative

There are no reported injuries associated with this event. The reported symptom relating a white residue noted in the system hld reservoir is likely attributed to the facility water quality (hard water) and interaction with metricide opa plus which can create precipitates as indicated in the hld manufacturer's product labeling. The reported symptom relating to a failure of the ultrasonics not functioning in bay 1 is attributed to liquid ingress onto the transducer crystal/nose and tail pc assembly, p/n 12061, causing a shorting condition that eventually led to the failure of the ultrasonic generator (500 w) board, p/n 12008, date code october 04, 2000. The cause for the liquid ingress could not be determined.

 
Event Description

During use, a white residue was noted in the system hld reservoir. The customer is using cidex opa for hld and tergal 800 for detergent. Additionally, it was noted by the facility biomed during a function test of the machine to verify performance that the ultrasonics in bay 1 were not functioning as intended. Bay 2 ultrasonics are functioning normally. Scopes being processed at the time were processed alternatively.

 
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Brand NameSYSTEM 83 PLUS 9
Type of DeviceENDOSCOPE WASHER AND DISINFECTOR
Manufacturer (Section D)
CUSTOM ULTRASONICS INC.
144 railroad drive
ivland PA 18974
Manufacturer Contact
elizabeth lazaro
144 railroad drive
ivyland, PA 18974
2153641477
MDR Report Key5097728
MDR Text Key26773712
Report Number3007082252-2015-00014
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 09/09/2015
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 Received09/09/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2000
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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