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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS

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COOK INC COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS Back to Search Results
Model Number G05533
Device Problem Difficult to Open or Close (2921)
Patient Problem No Code Available (3191)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative
Common name
=
device, biopsy, endomyocardial; (b)(4). (b)(4). 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 that during a biopsy, the cook flexible myocardial biopsy forceps did not close properly. Myocardial tissue was unable to be captured as a result. As no other forceps were available, the procedure was unable to be completed and was cancelled. Additional information regarding how the procedure was completed, event details, and patient outcome has been requested, but is not available at this time.
 
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Brand NameCOOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7194416
MDR Text Key97346375
Report Number1820334-2018-00149
Device Sequence Number1
Product Code DWZ
Combination Product (y/n)N
PMA/PMN Number
K883723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberG05533
Device Catalogue NumberFBFE-5.2-120
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2016
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: 01/16/2018 Patient Sequence Number: 1
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