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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 Problems Fracture (1260); Difficult to Open or Close (2921)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
Customer name and address- postal code: (b)(4). Pma/510(k) #¿ exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
As reported, the basket of an ngage nitinol stone extractor would not close and "snapped" during an unspecified procedure. No adverse events have been reported as a result of the alleged malfunction. Additional information has been requested regarding the patient and the event. At the time of this report, no further information has been provided.
 
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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 Key12435935
MDR Text Key270362863
Report Number1820334-2021-02110
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-017115
Device Lot Number13505627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2020
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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