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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. NCIRCLE DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK, INC. NCIRCLE DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number G18778
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 10/17/2017
Event Type  malfunction  
Event Description
During ureteroscopic case involving retrieving a stone, the stone extractor broke while surgeon was attempting to retrieve ureteral stone. It appears to flip on itself and broke. The piece of the basket that catches the stone broke off in the ureter and was retrieved without any patient harm.
 
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Brand NameNCIRCLE
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK, INC.
750 daniels way
bloomington IN 47404
MDR Report Key7013378
MDR Text Key91456311
Report Number7013378
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2019
Device Model NumberG18778
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number7326511
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2017
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer10/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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