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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 Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Investigation: a review of the complaint history, device history record, specifications, quality control and a visual inspection of the returned devices was conducted. Two ngage nitinol stone extractors were returned for evaluation. Device a was returned with the handle in the closed position. The basket formation was in the closed position. The collet knob was tight and secure. The male luer lock adaptor (mlla) was tight. The polyethylene terephthalate tubing (pett) measured 3. 5 cm in length. The handle actuated the basket formation, but did not close completely. A visual examination noted a kink in the basket sheath 106 cm from the distal tip. There was also a kink at the base of the support sheath. The handle was disassembled. The basket formation could be manually actuated to the open and closed positions. The handle was reset and reassembled; function test noted the handle actuated the basket formation to the open and completely closed positions now. Device b was returned with the handle in the closed position and the basket formation was partially closed. The collet knob was tight and secure. The male luer lock adaptor (mlla) is tight. The polyethylene terephthalate tubing (pett) measured 3. 5 cm in length. A visual examination noted the support sheath was bowed in appearance. A kink was noted in the basket sheath 106 cm from the distal tip. A functional test determined the handle did not actuate the basket formation. The handle was disassembled and the basket formation will not expand. Under magnification, a wire was noted to be broken 2 mm in length. The wires sheaths was accordioned. The complaint was confirmed for device b. A review of the device history record found no non-conformances were noted. A review of complaint history this to be the only reported complaint associated with complaint lot number 7796015. Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event. Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping. Review of production and quality documentation did not observe any specific issues with current manufacturing and quality controls that may have contributed to this incident. Based on the available information and the investigation results of the returned devices a definitive root cause could not be established. Measures have been initiated to address this failure mode. Cook medical will continue to monitor for similar complaints. As 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
The customer reported during a case, two ngage nitinol stone extractors were used. As reported, the basket formation would not close on either of these devices. No additional procedures were required as a result of the two basket formations not closing. No section of the device was left inside the patient's body. As reported, there were no adverse effects to the patient due to these issues. Additional patient and event detail has been requested.
 
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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 Key6777419
MDR Text Key257887112
Report Number1820334-2017-02297
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482968
UDI-Public(01)00827002482968(17)200331(10)7796015
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2017
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2017
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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