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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 Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2018
Event Type  malfunction  
Manufacturer Narrative
Patient code: no consequences or impact to patient. Device code: material split, cut or torn ((b)(4)) is not labeled. 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, the user selected the ngage nitinol stone extractor for transurethral urinary stone extraction. When he took the device out from the tray prior to patient contact, he found the red support sheath was severed already. The device was not used. He replaced it with another device to complete the procedure. Additional information received on (b)(6) 2018. The device is in a closed position. The actuator button works, but the basket does not open or close.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7828304
MDR Text Key118874252
Report Number1820334-2018-02622
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482944
UDI-Public(01)00827002482944(17)201226(10)8470477
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 09/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/26/2020
Device Catalogue NumberNGE-017115
Device Lot Number8470477
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2017
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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