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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
Model Number G48294
Device Problems Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: perioperative inventory manager. 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 when the doctor was performing the ureteroscopy, the first ngage basket would not completely open and shut properly. He tried using the device and while using it, the device started ¿shredding¿ down the plastic sheath. Another ngage was then opened and this basket would also not open and close properly. The case was completed as normal. No extra measures needed to be taken. No piece of the device was left in the patient. Additional patient and event information has been requested. At the time of this report, no additional information has been provided. This report captures the first basket malfunction reported to occur during the procedure. It is related to mfr. Report # 1820334-2019-00660 which addresses the second basket issue.
 
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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 Key8436831
MDR Text Key139342387
Report Number1820334-2019-00659
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482944
UDI-Public(01)00827002482944(17)220130(10)9486119
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2022
Device Model NumberG48294
Device Catalogue NumberNGE-017115
Device Lot Number9486119
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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