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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-022115-UDH
Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted. A review of complaint history, the device history record, quality control data, and specifications was also performed. One device was returned for investigation. The device was returned in used condition with the handle in the closed position and the basket formation in the closed position. The collet knob is tight and secure. The male lure lock adaptor (mlla) is finger tight. The polyethylene terephthalate tubing (pett) measures 2. 7 cm in length. The mlla was tightened and the basket formation still does not open fully. The length of the basket sheath is 115. 2 cm. The length of the basket formation that sticks out is approximately 1 cm. There are a few minor bends in the basket sheath that were visibly noted, possibly from how the device was returned for investigation. The basket sheath does have a couple of significant kinks, one at 21 cm from the support sheath and another at 22 cm from the distal tip of the support sheath. The width of the basket formation is 4 mm. A functional test noted the handle actuates the basket formation, but not to the fully open position. The length of the basket formation is 7 mm. The handle was disassembled. The basket formation could be manually actuated to the fully open position. The handle was reset and reassembled and the device then functioned as intended. 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. The device history record was reviewed and noted there were ten non-conforming items identified during manufacturing. Nine of the non-conforming items were scrapped. One non-conforming product was reworked. This item was identified to have a component, displaced in package. A review of complaint history revealed this is the only reported complaint associated with the complaint lot number 7850665. Based on the provided information a definitive root cause could not be established. 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
(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 user facility reported, during a ureteroscopy with fulguration procedure the ncircle tipless stone extractor basket was tested successfully prior to use. As reported, there was no stone to be removed. The basket was passed one time and a blood clot was pulled out. When attempting to use the basket again for the second time and before patient contact the basket would not fully open. There was no unintended portion of the device left inside the patient¿s body. The procedure was completed by opening and using a new ncircle tipless stone extractor. As reported, there were no adverse effects to the patient due to this occurrence.
 
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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 Key6768215
MDR Text Key273167338
Report Number1820334-2017-02291
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002187788
UDI-Public(01)00827002187788(17)200421(10)7850665
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 01/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH
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 Received01/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2017
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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