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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
Model Number G21363
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Initial reporter: custom person (address line 1): (b)(6). Product code: itx. Pma/510(k): k171272. (b)(4). 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
It was reported that a patient underwent a unknown procedure which involved the cook-swartz doppler flow probe standard cuff (dp-sdp001), in which an unknown portion of wire broke off during attempted removal of the device. The malfunction was not obvious to the provider who removed the device. The fragment of wire remaining in the patient was discovered several days later and remains in the patient, based on the information provided to the manufacturer. Additional information has been requested from the user facility regarding the patient outcome and device malfunction.
 
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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 Key11304624
MDR Text Key246297746
Report Number2522007-2021-00003
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG21363
Device Catalogue NumberDP-SDP001
Device Lot NumberN172688
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2020
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: 02/09/2021 Patient Sequence Number: 1
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