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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC LIVER ACCESS AND BIOPSY SET FCG KIT, NEEDLE, BIOPSY

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COOK INC LIVER ACCESS AND BIOPSY SET FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 12/03/2021
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #: preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported an unknown patient required placement of a liver access and biopsy set for an unknown procedure. During the procedure while removing the 5 french catheter, the hub dislodged. Additional information regarding event details has been requested but is currently unavailable.
 
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Brand NameLIVER ACCESS AND BIOPSY SET
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key12988837
MDR Text Key286353007
Report Number1820334-2021-02666
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLABS-100-J
Device Lot Number13678138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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