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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER

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COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER Back to Search Results
Catalog Number DP-SDP001
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/18/2020
Event Type  Injury  
Manufacturer Narrative
Product code: itx. Pma/510(k): k171272 the event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
The email documents attached to this complaint were received by customer support by a woman that underwent a double mastectomy procedure in (b)(6) 2019. According to the patient her physician used a cook-swartz doppler probe for the procedure and the tip of the probe later broke off inside the patient. Additionally, the patient stated that her physician wasn¿t planning to remove the wire. Recently the woman was diagnosed with nocardia; the infectious disease doctor ordered a chest ct and brain mri. Upon her arrival for the mri, medical personnel noted the doppler wire in her and couldn¿t perform the test. Due to a recent push to obtain an mri, the patient has questions and is requesting some feedback information about the doppler probe. Her doctors are assessing options with a strong likelihood of an additional surgery to remove the wire. On (b)(6) 2021, the fragment of the doppler probe was removed from the patient.
 
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Brand NameCOOK-SWARTZ DOPPLER PROBE
Type of DeviceDIAGNOSTIC ULTRASONIC TRANSDUCER
Manufacturer (Section D)
COOK VANDERGRIFT INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer (Section G)
COOK VANDERGRIFT INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer Contact
brian johnston
1186 montgomery lane
vandergrift, PA 15690
7248458621
MDR Report Key11508010
MDR Text Key253500002
Report Number2522007-2021-00011
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberDP-SDP001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/17/2021 Patient Sequence Number: 1
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