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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
Model Number N/A
Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2017
Event Type  malfunction  
Manufacturer Narrative
Follow-up communication with the sales representative determined that the two responses on the referenced questionnaire were incorrectly translated from (b)(6) language to english. The sales representative has advised that no part of the device separated during use. The device remained intact throughout its use. Investigation ¿ evaluation: one ngage nitinol stone extractor was received for evaluation. The device was returned with the handle in the closed position and the basket formation in the open position. The collet knob was tight and secure. The male luer lock adaptor (mlla) was tight. The polyethylene terephthalate tubing (pett) measures 3. 7 cm in length. A functional test determined the unidex handle (udh) does not actuate the basket formation. A visual examination noted the basket sheath has two kinks, one located at 33. 5 cm from the distal end of the support sheath and the other at 45. 5 cm from the distal end of the support sheath. The support sheath and basket sheath are still adhered. There was no damage noted on the basket formation. The udh was disassembled and the basket formation could not be manually actuated. The coil assembly appears to be stuck inside the basket sheath. 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 three non-conformances identified during the manufacturing process for the issue of foreign matter, embedded. A review of complaint history revealed this complaint to be the only complaint associated to complaint lot number 7452565. The definitive root cause of this device issue could not be determined and no conclusion can be drawn. Measures have been initiated to address this failure mode. 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
Correction: during file review, it was noted that additional information previously not noted, was received on june 30, 2017 in email correspondence as an attachment questionnaire. The information found conflicts with the original event description provided to the manufacturer. The information was found in two responses on the questionnaire indicating, the device separated during use and was retrieved from the patient¿s kidney using a wolf cobra. The investigation remains in process. Follow-up is being performed to determine the information that is accurate. A final report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information and/or completion of the investigation.
 
Event Description
It was reported that during the flexible ureterorenoscopy (flex uri) procedure the ngage nitinol stone extractor basket would not open due to its twisted configuration. The procedure was finished with another device. A section of the device did not remain inside the patient nor did the patient require any additional procedures as a result of the 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 Key6732613
MDR Text Key254360243
Report Number1820334-2017-01829
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482975
UDI-Public(01)00827002482975(17)191117(10)7452565
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received10/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2016
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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