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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 Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
Evaluation / investigation: a review of complaint history, device history record, quality control and specifications was performed. A visual inspection of the device was also conducted. One ncircle tipless stone extractor was returned for evaluation. The basket formation has been detached from the coil assembly and the basket was not returned. The collet knob was tight and secure. The male luer lock adaptor (mlla) was tight. The support sheath and the basket sheath remained attached. The coil assembly was found to have an offset coil 1. 5 mm from the tip. The distal cannula is also missing. There are no visible wires. 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 review was performed. Two nonconformance's were noted; however, both of the units were scrapped. A review of complaint history found there have been no other complaints received for this device lot number. Based on the provided information and the investigation evaluation a definitive root cause for the reported issue could not be determined. 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
Concomitant medical products- boston sci lithovue ureteroscope. (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 during a ureteroscopy laser lithotripsy an ncirlcle tipless stone extractor was used. While extracting the stone, the basket broke in the kidney. A 3. 2 alligator was used to retrieve it. The laser and basket were not used in the scope at the same time. No parts of the device remained inside the patient's body as a result of this product problem. The procedure reportedly concluded as normal.
 
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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 Key6732655
MDR Text Key258562524
Report Number1820334-2017-01803
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002187788
UDI-Public(01)00827002187788(17)200302(10)7717450
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 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
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 Received11/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/21/2017 Patient Sequence Number: 1
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