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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 10/31/2017
Event Type  Injury  
Manufacturer Narrative
Investigation/evaluation summary: the device was inspected under magnification and confirmed the customer's complaint that the cuff became detached from the crystal. A functional test was performed on the probe and an audible pulse sound was verified. No other nonconformities or anomalies were observed on the device. A review of the device history record and manufacturing and quality control records was conducted. There is no evidence that defective product was manufactured using current drawings and device specifications. Complaints will continue to be monitored according to established complaint monitoring procedures.
 
Manufacturer Narrative
(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
The international customer reported that the cook-swartz doppler probe crystal came off prematurely at the end of surgery. The operator had to replace the crystal and re-open the patient's neck. The circumstances surrounding the usage and handling of the device leading up to the product malfunction were not reported. The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
 
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Brand NameCOOK-SWARTZ DOPPLER PROBE
Type of DeviceITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
COOK VASCULAR INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7088265
MDR Text Key195844000
Report Number2522007-2017-00047
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K022649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberDP-SDP001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2017
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: 12/06/2017 Patient Sequence Number: 1
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