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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE GE IC5-9D IC5-9D TRANSVAGINAL US PROBE

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GE GE IC5-9D IC5-9D TRANSVAGINAL US PROBE Back to Search Results
Model Number 5194434
Device Problems Crack (1135); Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2017
Event Type  malfunction  
Event Description
Ge transvaginal ultrasound model ic5-9d, cracks discovered on probes from multiple va facilities within our visn. Va in popular bluff, mo has received new probes from ge and those devices also have the same defect. Under magnification it is seen pieces of what looks like a seal missing all around the ring. These have been taken out of service at multiple va visn 15 facilities as fluid may be able to enter these cracks and not be effectively cleaned, though covered with sterile sheath during examinations. It states in manufacturer ifu not to use device if cracks are discovered.
 
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Brand NameGE IC5-9D
Type of DeviceIC5-9D TRANSVAGINAL US PROBE
Manufacturer (Section D)
GE
wichita KS 67218
MDR Report Key6307551
MDR Text Key66778161
Report NumberMW5067705
Device Sequence Number1
Product Code ITX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5194434
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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