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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS GF UC140P-AL5 TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS GF UC140P-AL5 TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number GF-UC140P-AL5
Device Problem Insufficient Information (3190)
Patient Problems Fever (1858); Unspecified Infection (1930); Chills (2191)
Event Date 07/31/2015
Event Type  Injury  
Event Description
The patient had ercp and egd approximately one month ago; developed fever/chills 3 days later. Eus scope tested positive for cre. Unknown if patient was infected prior to egd or not.
 
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Brand NameOLYMPUS GF UC140P-AL5
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
OLYMPUS CORPORATION OF THE AMERICAS
3500 corporate pkwy
center valley PA 18034
MDR Report Key5090770
MDR Text Key26270209
Report Number5090770
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberGF-UC140P-AL5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2015
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2015
Event Location Hospital
Date Report to Manufacturer08/27/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/21/2015 Patient Sequence Number: 1
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