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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 Degraded (1153); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2018
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 initially reported the ngage nitinol stone extractor was not working properly. The staff had to open another one. Additional information previously requested was received on 27sep2018. As reported, the procedure was cystoscopy, ureteroscopy, stone laser lithotripsy, and stone extraction. The basket was opened and closed prior to use in an uncoiled position. A laser was used during the procedure but not simultaneously while the basket was being used. The scrub tech kept the handle pointed in the direction the surgeon was going- toward the patient. The scrub tech tested opening and closing when the device was removed from the package initially. She closed the device when a stone was captured. Opened, when stone was removed from the body. Sometimes the device will be opened when the surgeon reaches the bladder. The device with stone intact is not pulled thru the digital scope. The stone is always under direct visualization of the surgeon. The scope that was used was an olympus urf-v2r. The inner channel diameter is 3. 6 fr (1. 2 mm) the distal end of the scope is 8. 4 fr. No parts were separated but it did appear that the coating was coming loose. The surgeon ended up using a competitor's device. The stone sizes were originally 6 and 7 mm stones.
 
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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 Key7929795
MDR Text Key122485127
Report Number1820334-2018-03018
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2021
Device Catalogue NumberNGE-017115
Device Lot Number8664244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2018
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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