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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
Catalog Number NTSE-015115
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma/510k # - exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported, during a transurethral ureterolithotripsy (tul) procedure, the physician conducted a functional test of the ncircle tipless stone extractor, prior to insertion into the patient's body and found that the basket could not be opened/closed. Another ncircle tipless stone extractor was used without problems and the procedure was completed successfully. No patient involvement.
 
Event Description
It was reported, during a transurethral ureterolithotripsy (tul) procedure, the physician conducted a functional test of the ncircle tipless stone extractor, prior to insertion into the patient's body and found that the basket could not be opened/closed. Another ncircle tipless stone extractor was used without problems and the procedure was completed successfully. No patient involvement.
 
Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted. A document based investigation was also performed. This included a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data. One device was returned for investigation. The device was returned with the handle and basket formation in the open position. A visual examination noted that 2 cm of the coil was extending from the distal tip of the basket sheath. Both the collet knob and the male luer lock adapter (mlla) were loose. The polyethylene terephthalate tubing (pett) measures 3 cm in length. It was noted the cannulated handle is not ¿caught¿ in the collet. The support sheath curves at the nose of the mlla. There were no kinks noted in the basket sheath. A functional test determined the handle does not actuate the basket formation. The handle was disassembled. The support sheath and basket sheath are still adhered. The basket formation can be manually actuated to the open and closed positions. The handle was reset and reassembled and the device was found to function as intended. The device history lot record was reviewed and noted there were no non-conformances associated with the reported failure. A search of complaint records found this is the only complaint associated with the complaint device lot number 8565788. The following information is included in the instructions for use (ifu) that accompanies this device in the precaution section: enclose the device in the sheath before removing from the tray/holder. Do not use excessive force to manipulate this device. Damage to the device may occur. The complaint device was found to have a basket that would not close due to the cannulated handle having separated from the collet knob that holds it in place. With the cannulated handle not being held by the collet knob the motion of the handle could not function the basket. No damage to the device was found. The support sheath was curved, but this most likely occurred after the cannulated handle became separated. The collet knob was found to be loose, indicating that it was likely not tightened appropriately during device manufacture. The cause for this issue is manufacturing related - operator related. The operator for the complaint device associated work order was retrained to the operation of securing the handle cannula with the collet knob. Cook medical will continue to monitor this device via the complaints database for similar complaints.
 
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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
MDR Report Key7655378
MDR Text Key113002478
Report Number1820334-2018-02029
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 foreign,health professional,o
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/06/2021
Device Catalogue NumberNTSE-015115
Device Lot Number8565788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2018
Is This a Reprocessed and Reused Single-Use Device? No

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