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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 G17627
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510k #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that during a trans-ureteral lithotripsy, a ncircle tipless stone extractor was inserted in a ureteroscope "when a fray on the sheath" was found 1 cm from the blue protective sheath. After this fray was discovered "they continued using the device. " the user was able to "capture" the stone with the basket, but found that the basket stopped actuating. The user then used "force" to slide the lever, but broke a wire. The device then became stuck within the patient's body, so the operator then disassembled the handle and pulled the wire from the proximal tip of the handle, which caused the stone to be released from the basket. The operator was then able to remove the device from the patient's body. Another ncircle tipless stone extractor was used to complete the procedure. No adverse effects to the patient were reported to have occurred due to this event.
 
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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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9119931
MDR Text Key176456352
Report Number1820334-2019-02414
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/22/2021
Device Model NumberG17627
Device Catalogue NumberNTSE-030115-UDH
Device Lot Number9251803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2018
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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