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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 Perforation of Vessels (2135)
Event Date 04/27/2021
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
Following the completion of the removal of the aggressive maxilla orbital h&n tumor, two flaps were harvested for the reconstruction. A fibula free flap was used for the reconstruction of the maxilla and an alt flap to close the soft tissue. Both free flaps had a dp-sdp001 placed around the artery. 10 days post operation and after no issues in blood flow was detected, the probes came to be removed. Removal was performed on the h&n ward by a ward nurse who wasn't completely familiar with the cook doppler probe. The fibula flap monitor probe was removed easily with no incident. Upon removal of the alt flap it was reported that excessive force was required to remove wire and caused pain to patient. 24 hours later the alt flap was found to have an issue with blood flow and the patient returned to operating room for revision surgery. Upon opening, the arterial vessel leading to blood flow loss was separated and the flap had failed due to duration of ischemia. Afterwards, an alternative pectoralis major flap was harvested to anastomose to the vein of the recipient site. This led to a further 9 hour surgery and prolonged in-patient stay in hospital.
 
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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
MDR Report Key11875903
MDR Text Key266244315
Report Number2522007-2021-00017
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,foreign,health profe
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
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
Was the Report Sent to FDA?
Event Location No Information
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: 05/25/2021 Patient Sequence Number: 1
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