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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
Event Date 10/29/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
The device was advanced through an ureteroscope and placed in the kidney and urinary duct.During repetitive manipulation of the device to remove the crushed stones in the urinary tract, the basket wire broke, which prevented the basket from forming the intended shape.Another device was used instead.The patent recovered on the same day.
 
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Brand Name
NCIRCLE TIPLESS STONE EXTRACTOR
Type of Device
FFL 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
8128294891
MDR Report Key7137294
MDR Text Key95945038
Report Number1820334-2017-04539
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002462069
UDI-Public(01)00827002462069(17)180709(10)6019883
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 Physician
Type of Report Initial
Report Date 12/21/2017
1 Device was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNTSE-015115
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2017
Initial Date FDA Received12/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2015
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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