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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 Problems Difficult to Remove (1528); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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
The customer has previously reported that during a ureteroscopy using a cook ncircle tipless stone extractor for a stone retrieval procedure, when the basket was tightened around the stone, the shaft's end split and opened up so that when it was reintroduced into the unspecified scope, the scope broke. It was reported that they have had 5 scopes breaking like this when using the ncircle device. As these 5 events had not been previously been reported to cook, this complaint was opened and filed to capture that information. The area representative stated that these incidents weren¿t reported to cook previously, because the customer was not certain of the reason for the breakages when they first occurred. The procedures were done by junior residents and initially it was thought that the reason for scope breakage was due to misuse of the scope. It is unknown what the lots are at this time, nor if the devices are available for return. No adverse events have been reported as a result of the alleged malfunction. Additional product, event, and patient information has been requested. At the time of this report, no further 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 Key8223722
MDR Text Key132360533
Report Number1820334-2019-00040
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/25/2021
Device Catalogue NumberNTSE-015115
Device Lot Number9260673
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2018
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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