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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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GE HEALTHCARE JAPAN CORPORATION SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number IC5-9-D
Device Problems Material Separation (1562); Component Missing (2306); Device Contamination with Body Fluid (2317); Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2017
Event Type  malfunction  
Event Description
It was noticed during cleaning that a transducer after a prostate biopsy that blood had collected where the handle meets the transducer, it has what looks like a ring or ridge all the way around the device. After cleaning the transducer we inspected it under a magnifying lens and could see pieces of what looks like a seal is missing all round this ring. We took the device out of service, contacted our radiology department, infection control and the specialty clinic nurse manager. Ge was contacted. Pictures were taken with a microscope and sent to ge, which ge acknowledged this was an issue and replaced the devices. Two new transducers from ge were received and upon inspection these devices had the same issue. Ge was again notified and pictures sent. Ge confirmed that another two new transducers will be sent. These devices also had the same issue. It is important to note that the concern with the seal area was not visible to the naked eye and therefore would go undetected unless there was close inspection using a microscope. It was also noted that the transducer had a sharp area where the needle guide attached to the probe. As a result of this initial facility report, (b)(6) action was taken to remove these transducers from service to prevent the potential for patient harm. The investigation is ongoing, but initial findings have identified approximately (b)(4) devices with seal separation and (b)(4) had debris identified in the gap. The seal separation provides a space for bioburden to remain, possibly even after reprocessing, which poses a serious public health risk.
 
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Brand NameNA
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
GE HEALTHCARE JAPAN CORPORATION
9900 w. innovation drive
rp-2138
wawatosa WI 53226
MDR Report Key6338625
MDR Text Key67671337
Report Number6338625
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/15/2017
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? Yes
Date Report Sent to FDA02/15/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/15/2017
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

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