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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number N/A
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation: a review of device history record, documentation, specification, instructions for use (ifu), complaint history, and visual inspection of the returned device was conducted during on the returned product during the investigation. No issues were found related to the reported complaint. One device was returned for investigation. The device was returned with the handle in the open position. It was observed that the basket sheath and coil has been severed from the nose of the male luer lock adapter (mlla). A visual examination noted that the basket coil was extended beyond point of separation. The support sheath was found bowed in appearance. A severe kink was noted 4cmfrom the point of separation on the basket sheath. The mlla was found finger tight. The collet knob was found tight and secure. The handle actuated what is left of the basket coil. The distal tip appears curved and is smashed. The points of separation appeared cut. 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 and device integrity prior to shipping. 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. Review of the device history record of the finished product shows no nonconforming events that would contribute to the reported failure mode. There were no other reported complaints for this lot number. Based on the information provided and the results of our investigation; a definitive root cause could not be determined. Measures have been initiated to correct this issue. Monitoring will continue to be performed 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
It was reported that while the physician was performing an unspecified procedure on a patient using an ncircle tipless stone extractor device. The physician discovered that the device broke in the middle of the procedure. The physician further stated that the ureteroscope was damaged as there was a leak after the procedure. Additional information was requested; however it is not available at this time.
 
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Brand NameNCIRCLE TIPLESS 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 Key6800433
MDR Text Key258906067
Report Number1820334-2017-02519
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002462069
UDI-Public(01)00827002462069(17)191220(10)7535372
Combination Product (y/n)N
Reporter Country CodeFR
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 11/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberNTSE-015115
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 Received11/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2016
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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