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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 Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation: a review of functional testing, drawing, manufacturing instructions, visual inspection, and quality control data was conducted during the investigation. Visual inspection and functional testing of the returned device were performed. The returned device was found to be non-functional, the basket would not fully close. Multiple kinks were observed along the sheath. The observed kinks prevented the basket from fully closing. All devices are 100% inspected for functionality and integrity before packaging. It is likely the damage occurred when removing the device from the packaging, or subsequent handling. Current controls are in place in manufacturing to assure device functionality prior to shipping. Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident. There is no indication that a design or process related failure mode contributed to this event. The root cause of this event is product use or handling related ; operational or environmental context. Per the quality engineering risk assessment, no further action is required. Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
It was reported while prepping for a ureteroscopy, the device was tested and the user found the device would open but would not fully close. This device was not used for the procedure. There was no adverse event.
 
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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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7126827
MDR Text Key252739070
Report Number1820334-2017-04426
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482975
UDI-Public(01)00827002482975(17)201108(10)8357609
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 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-022115
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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