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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-MB
Device Problems Stretched (1601); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2017
Event Type  malfunction  
Manufacturer Narrative
One ngage nitinol stone extractor was received for an evaluation. The device was returned with the handle in the closed position. A visual examination noted the basket assembly has been severed 4 cm from the distal tip-part. The cannula is still adhered. One wire protruding from offset coil is less than 1 mm. The wire has broken off from the offset coil. One wire is protruding the coil assembly approximately 5 mm. The polyethylene terephthalate tubing (pett) measures 3. 4 cm in length. The basket sheath has no kinks but has been severed in four places. There is a 4 mm piece of basket sheath that is severed; one piece measures 5 cm, one piece measures 1mm and then the main segment. The 5 cm segment has two wires extending; one at 6 mm from the point of separation and one 2 mm from the point of separation on the proximal end. The braiding is exposed from the basket sheath on the proximal end. The distal end of the 5 cm segment has the all the basket wires pulled out. The basket formation is flat and twisted. The collet knob is tight and secure. The male luer lock adaptor (mlla) is tight. The handle actuates the basket assembly. The complaint is confirmed. It appears this device has met resistance beyond its intended design. Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event. A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident. A review of the device history record showed there were no non-conformances identified during the manufacturing process. A review of complaint history for this product/lot number combination revealed no other complaints have been received. 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
The user facility reported the ncircle tipless stone extractor was used during a stone extraction procedure. After using the device to extract kidney/ureter stones 2 or 3 times, the inner wire/sheath had stretched and the basket would no longer close. The open basket could not be pulled into the ureteroscope. The surgeon removed the basket and the ureteroscope together from the patient and cut the basket sheath to remove the extractor from the ureteroscope. Another ngage nitinol stone extractor was utilized to complete the procedure. As reported, there were no adverse effects to the patient due to this occurrence.
 
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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 Key6768213
MDR Text Key253202515
Report Number1820334-2017-02165
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-022115-MB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2017
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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