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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENCIL TIP DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER

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PENCIL TIP DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 01/11/2021
Event Type  malfunction  
Event Description
Patient undergoing an emergency endovascular procedure for acute ischemia of his lower extremities. The following procedures were performed: a left common femoral artery access with ultrasound guidance right lower extremity arteriogram. Open right iliac thromboembolectomy. Right common iliac and external iliac artery stent (smart 8 mm x 60 mm). During the open procedure, a doppler was used to assess blood flow. A metal piece from the doppler probe tip fell off and into the open incision. The probe tip was found and removed from the incision. A new probe was obtained to finish the procedure. The surgeon stated after removal of the tip, he dropped it on the floor and staff were unable to locate the broken tip. The device apparently had been used for some time and was retired.
 
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Brand NamePENCIL TIP DOPPLER PROBE
Type of DeviceDIAGNOSTIC ULTRASONIC TRANSDUCER
MDR Report Key12075880
MDR Text Key261507642
Report Number12075880
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/14/2021
Event Location Hospital
Date Report to Manufacturer06/28/2021
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 Unkown

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