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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 Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2016
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation. A review of documentation, device history record, complaint history,manufacturing instructions, instructions for use, specifications and quality control data, and functional testing and visual inspection of the returned device were conducted during the investigation. A review of production and quality documentation did not observe any specific issues with current manufacturing that may have contributed to this incident. Review of the device history record showed one non-conformance that may be related to the complaint condition. There were no other reported complaints for this lot number. The ncircle tipless stone extractor is shipped with instructions for use (ifu), which clearly states the proper warnings, precautions, and instructions for use. A visual examination noted "the basket sheath had multiple kinks throughout the sheath. A functional test was performed and the udh handle would not actuate the basket formation to the open or closed position. ¿ based on the provided information a definitive root cause cannot be established or reported at this time. We will notify the appropriate personnel and continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation.
 
Event Description
It was reported by the user facility that a patient underwent an ureteroscopy procedure using an ncircle tipless stone extractor. The attending physician indicated that after advancing into the patient, the basket appeared to be tangled. The basket was replaced and the procedure was able to be completed. No unintended sections of the device remain inside the patient¿s body nor did the patient experience any additional procedures or adverse effects due to this occurrence. No further information was provided.
 
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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 Key6331343
MDR Text Key196069571
Report Number1820334-2017-00177
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002187788
UDI-Public(01)00827002187788(17)191004(10)7328552
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2016
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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