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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NGE-022115
Device Problem Difficult to Open or Close (2921)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation
=
non-healthcare professional - unknown. Pma/510(k) number
=
exempt. 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 the basket of a ngage nitinol stone extractor did not function properly during a ureteroscopy with stone extraction. It is unknown if a section of the device remained inside the patients body. It is unknown if the patient required any additional intervention due to this occurrence. It is unknown if the patient experienced any adverse effects due to this occurrence. Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.
 
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Brand NameNGAGE NITINOL STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
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
8128294891
MDR Report Key12519695
MDR Text Key272925747
Report Number1820334-2021-02204
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002482972
UDI-Public(01)10827002482972(17)240715(10)14091024
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-022115
Device Lot Number14091024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2021
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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