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U.S. Department of Health and Human Services

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

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COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER Back to Search Results
Model Number N/A
Device Problem Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 12/20/2017
Event Type  Injury  
Manufacturer Narrative
Changed-device evaluated by mfg. : yes. Investigation summary: two devices for this complaint were returned for an investigation. A visual inspection and product evaluation was performed and complaint was confirmed that the cuff became detached from the crystal on sample 1, sample 2 still had the cuff attached to the crystal as designed. A dhr review was conducted, manufacturing and quality control records were reviewed and there is no evidence that defective product was shipped. There are no signs that this cuff was detached prior to shipment or that this device was not manufactured to current specifications. A quality engineering risk assessment concluded that no risk reduction is necessary. Investigation results concluded through visual inspection one cuff separated from crystal and the other probe remained intact. No other nonconformities or anomalies were observed on these devices.
 
Manufacturer Narrative
Blank fields on this form indicate information s unknown or unavailable. Product code: itx. (b)(4). Event is currently under investigation. A follow-up/final report will be submitted upon receipt of additional information or completion of investigation. Blank fields on this form indicate information s unknown or unavailable.
 
Event Description
It was reported that the patient underwent a neck flap surgery and two doppler probes were placed to monitor blood flow, one on the artery and one on the vein. The signal from the probes was lost post-operatively and the patient was taken back to the operating room for an additional surgery to replace the probes. Upon retrieval of the initially placed probes, it was discovered there was a loose connection at the cuff. New probes were placed successfully and no additional consequences to the patient were reported.
 
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Brand NameCOOK-SWARTZ DOPPLER PROBE
Type of DeviceDIAGNOSTIC ULTRASONIC TRANSDUCER
Manufacturer (Section D)
COOK VASCULAR INC
1186 montgomery lane
vandergrift PA 15690
MDR Report Key7236929
MDR Text Key289488059
Report Number2522007-2018-00005
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K022649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberDP-SDP001
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 02/02/2018 Patient Sequence Number: 1
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