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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 Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation: a review of the device history record, documentation, drawings, manufacturing instructions, quality control data, and specifications was performed. Visual inspection and functional testing of the returned device was also conducted during the investigation. One ngage nitinol stone extractor was returned for evaluation. The device was returned with the handle and the basket formation partially open. The collet knob is tight and secure. The male luer lock adaptor (mlla) is tight. The polyethylene terephthalate tubing (pett) measures 3 cm in length. A visual examination noted the proximal segment of the support sheath is severed 1. 5 cm from the nose of the mlla. The support sheath and the basket sheath are detached. The distal segment of the support sheath measures 2. 5 cm up to the point of separation. The distal segment is still attached. The handle does not actuate the basket formation. Kinks were noted on the basket sheath 1. 5 cm, 34 cm, and 40 cm from the distal tip. The handle was disassembled. The basket formation could not be manually actuated. 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. The device history record was reviewed and two non-conformances were identified. The issues identified were loose debris and the wrong inserter. The items with these issues were reworked. A review of complaint history revealed there have been no other complaints associated with complaint device lot number 7845868. Based on the provided information a definitive root cause cannot be established or reported. However, appropriate measures have been initiated to address this failure mode. 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 customer reported during the ureteroscopic lithotripsy (ursl) procedure the physician used an ngage nitinol stone extractor to grasp the stone for the first time. As reported, the connection at the yellow line was broken and the basket wire would not work correctly. The physician chose to use a new ngage nitinol stone extractor to complete the procedure. No section of the device remained inside the patient. No additional procedures were required as a result of this occurrence. There was no adverse consequence or impact to the patient.
 
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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 Key6789039
MDR Text Key257244430
Report Number1820334-2017-02516
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482968
UDI-Public(01)00827002482968(17)200420(10)7845868
Combination Product (y/n)N
Reporter Country CodeTW
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 12/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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