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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 Difficult to Remove (1528); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2017
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, drawings manufacturing instructions, quality control data, and specifications was also performed. One device was returned for investigation. The lot number on the returned device is 8148161. The device was returned with the handle is in the open positions. The collet knob is tight and secure. The male lure lock adaptor (mlla) is loose. The polyethylene terephthalate tubing (pett) measures 2. 5 cm in length. The support sheath is bowed. A visual examination noted the basket formation is detached from the coil assembly. The wires in the basket formation have been severed and have the appearance on being pulled. It appears the device met resistance beyond its intended design. The device history record was reviewed and noted there were two non-conformances associated with the complaint device lot number. One nonconformance noted a documentation error that was corrected. The second non-conformance was for identified as basket/grasper retraction depth incorrect. This item was scrapped. A review of complaint history revealed this to be the only complaint report associated with complaint lot number 8148161. 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. Based on the provided information and evaluation, the root cause is possibly related to product use and handling. Measures have been initiated to address this failure mode. 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 area representative reported during a ureteroscopy procedure performed on (b)(6) 2017, the ncircle tipless stone extractor was used to retrieve a stone. While in use, the basket broke off at the neck of the basket leaving the basket in the patient. A second ncircle tipless stone extractor was used and it also broke off in the same way. When the third ncircle tipless stone extractor was put into use, it would not work properly and it had to be disassembled to remove it from the patient. This basket did not break off. The procedure could not be completed. The patient had to come back to have basket fragments removed and the ureteroscopy procedure completed. The basket fragments were removed using a different device. There were no adverse effects to the patient during the interventional surgery. Additional event and patient information has been requested. Three related reports have been filed to capture each of the three device malfunctions reported to occur during one procedure. Mfr. Report # 1820334-2017-03515 captures the first basket, mfr. Report # 1820334-2017-03517 captures the second basket and mfr. Report # 1820334-2017-03519 captures the third basket used in the procedure.
 
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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 Key6936966
MDR Text Key269388002
Report Number1820334-2017-03519
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
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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