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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-017115
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Event Description
As reported, during soft ureteral lithotripsy, when the package of an ngage nitinol stone extractor was opened, it was discovered that the basket would not open. The issue with this device was discovered prior to making contact with the patient and it was not used. A new basket was used to complete the procedure. There was no impact to the patient.
 
Manufacturer Narrative
Name and address: phone: (b)(6). Pma/510k # ¿ exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
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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 Key13025111
MDR Text Key289512862
Report Number1820334-2021-02711
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/05/2022
Device Catalogue NumberNGE-017115
Device Lot Number9927426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2019
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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