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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 Problem Material Separation (1562)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
At the time of this report, the evaluation/investigation is in progress. Occupation: lead surgical tech. Pma/510(k) # - exempt. (b)(4). 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 initially reported in mfr. Report # 1820334-2019-00290, that all three ncircle tipless stone extractor baskets broke in a similar fashion as we were trying to retrieve stones from the kidney, with the same lot number. All baskets broke without much effort or strain. This report is being filed for a 4th ncircle tipless stone extractor that was returned along with the three extractors related to the event mentioned above. A visual examination of the 4th returned device found one wire in the basket formation has pulled out of the distal cannula. Multiple attempts have been made to obtain event information related to the use of the 4th device. At the time of this report, no information has been forthcoming.
 
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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 Key8359034
MDR Text Key136891237
Report Number1820334-2019-00372
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2021
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number9379723
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2018
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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