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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 Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 08/21/2017
Event Type  malfunction  
Manufacturer Narrative
A review of complaint history, device history record, documentation, manufacturing instructions, specification and quality control data and visual inspection was conducted during the investigation. One device was returned for investigation. The device was returned with the handle in the open position. The collet knob was tight and secure. The mlla (male luer lock adaptor) was found tight. The support sheath was bowed in appearance. The basket assembly was severely kinked at the end of the support sheath. A functional test noted the handle did not actuate the basket formation. A visual examination noted the basket sheath was partially severed at the kinked area. The basket formation was symmetrical in appearance. The support sheath and the basket sheath were still adhered. The handle was disassembled and the basket formation could not be manually actuated. It appears the device met resistance beyond its intended design. A 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. A review of the device history record found no other non-conformances and a review of complaint history search found no other complaints associated with the complaint device lot number. Based on the provided information, inspection of returned product and the investigation, a definitive root cause cannot be established or reported at this time. We will notify the appropriate personnel and continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
 
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 that during preparation and prior to performing a procedure, the operator found that the ngage nitinol stone extractor basket could not open. The device did not come in contact with a patient. As reported the device was not used on a patient; no patient involvement and no patient impact.
 
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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 Key6809527
MDR Text Key254356286
Report Number1820334-2017-02687
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482975
UDI-Public(01)00827002482975(17)200609(10)7978629X
Combination Product (y/n)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2017
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 Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2017
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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