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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 Kinked (1339); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Investigation ¿ evaluation: one ncircle tipless stone extractor was received for evaluation. Visual inspection of the device noted the device was returned with the unidex handle (udh) and the basket formation in the closed position. The support sheath is bowed in appearance. The support sheath and the basket sheath remain adhered. The basket sheath is smashed in 3 locations within 2 cm of the distal tip and 5 mm of the distal tip is collapsed. The polyethylene terephthalate tubing (pett) measures 2. 5 cm in length. Functional testing was performed. The collet knob is tight and secure. The male luer lock adaptor (mlla) is loose to the touch. The udh handle does not actuate the basket formation. The customer complaint has been confirmed. Most likely, the damage to the basket sheath is preventing the device from functioning as intended. A definitive root cause for the device failure cannot be determined. 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 there were no non-conformances identified during the manufacturing process that would have caused or contributed to the reported product issue. A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received. 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
It was reported that during an intended ureteroscopy, the physician attempted to use ncircle tipless stone extractor device. The physician noticed that the device was not working as intended. The physician removed the device and noted a dent/kink on the device cannula. The physician replaced the device with another ncircle tipless stone extractor device and noticed the same result. A separate complaint was opened for this device. The physician completed the procedure by using the third ncircle tipless stone extractor. No unintended section of the device remained inside the patient's body. According to the initial reporter, the patient did not experience any adverse effects 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 Key6681377
MDR Text Key209974461
Report Number1820334-2017-01533
Device Sequence Number1
Product Code FFL
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 08/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received08/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2017
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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