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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-015115
Device Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Pma/510k #: exempt. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported, during an unspecified procedure using a ncircle tipless stone extractor, the device broke and fell apart. The basket was used to successfully remove one stone from the kidney on the first attempt. The scrub nurse held the device until the surgeon was ready to insert the device back into the scope. It was at this point they noticed that where the wire is covered by the red plastic near the handle, it was bent at a weird angle and the device would no longer work. Another similar device was opened and used to complete the procedure. No known adverse events have been reported as a result of the alleged malfunction. Additional details have been requested regarding the patient and event. At this time no additional information has been 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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9155806
MDR Text Key161215784
Report Number1820334-2019-02533
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-015115
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2019
Was Device Evaluated by Manufacturer? Yes
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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