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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COOK MEDICAL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INCORPORATED COOK MEDICAL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2020
Event Type  malfunction  
Event Description
Basket would not open when surgeon would push black piece to open and close; upon further trying basket did open but surgeon was not okay with damage that had been done to basket tip. Another one was opened and used on patient.
 
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Brand NameCOOK MEDICAL
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key10127847
MDR Text Key194340407
Report Number10127847
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/02/2020
Event Location Hospital
Date Report to Manufacturer06/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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