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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT LABORATORIES PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS 7F FORCEPS, BIOPSY

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ST. JUDE MEDICAL / ABBOTT LABORATORIES PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS 7F FORCEPS, BIOPSY Back to Search Results
Model Number 408298
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2018
Event Type  malfunction  
Event Description
The biopsy forceps stopped working in the middle of a heart biopsy procedure. Required a new forceps to be used. No harm to the pt.
 
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Brand NamePROCURE ENDOMYOCARDIAL BIOPSY FORCEPS 7F
Type of DeviceFORCEPS, BIOPSY
Manufacturer (Section D)
ST. JUDE MEDICAL / ABBOTT LABORATORIES
plymouth MN 55442
MDR Report Key7742702
MDR Text Key115988883
Report NumberMW5078788
Device Sequence Number1
Product Code DWZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model Number408298
Device Catalogue Number408298
Device Lot Number9915655
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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