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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-MB
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # - exempt. (b)(4). 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 during a stone retrieval procedure, the ngage nitinol stone extractor basket failed to deploy once in the renal calyx. A new basket was used to complete the procedure. No unintended section of the extractor remained inside the patient¿s body. No additional procedures were required due to this occurrence. There were no adverse effects to the patient.
 
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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 Key7851633
MDR Text Key119663093
Report Number1820334-2018-02619
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeZA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2021
Device Catalogue NumberNGE-017115-MB
Device Lot Number8661849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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