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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 No Consequences Or Impact To Patient (2199)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
Customer name and address- postal code: (b)(6). 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
As reported, when testing the device prior to use for a transurethral lithotripsy, the basket of an ngage nitinol stone extractor was able to be closed, but could not be opened. The device did not make patient contact. The procedure was completed with another device of the same type. The patient did not experience any adverse effects due to this occurrence.
 
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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
8123392235
MDR Report Key11091154
MDR Text Key224391819
Report Number1820334-2020-02382
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002482972
UDI-Public(01)10827002482972(17)230914(10)13426447
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-022115
Device Lot Number13426447
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2020
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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