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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE GE LOGIQ E9 ENDOCAVITY ULTRASOUND PROBE

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GE GE LOGIQ E9 ENDOCAVITY ULTRASOUND PROBE Back to Search Results
Model Number IC5-9-D
Device Problems Break (1069); Material Separation (1562); Scratched Material (3020)
Patient Problem No Information (3190)
Event Date 01/26/2017
Event Type  malfunction  
Event Description
Ge endocavity ultrasound probe issue consisting of broken seal gap and burr identification. Five separate veteran affairs medical center sterile processing departments have reported a line of separation between the probe tip and handle and a "burr" at the distal tip. The issue was first reported by the (b)(6).
 
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Brand NameGE LOGIQ E9 ENDOCAVITY ULTRASOUND PROBE
Type of DeviceENDOCAVITY ULTRASOUND PROBE
Manufacturer (Section D)
GE
MDR Report Key6348975
MDR Text Key68151513
Report NumberMW5068003
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 02/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIC5-9-D
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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