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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED NCIRCLE NITINOL TIPLESS STONE EXTRACTOR DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INCORPORATED NCIRCLE NITINOL TIPLESS STONE EXTRACTOR DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number G18778
Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/16/2020
Event Type  malfunction  
Event Description
During cystoscopy with ureteroscopy with removal/manipulation of stones, a small piece of the distal portion of the ncircle nitinol tipless stone extractor from cook medical broke off. Piece was unable to be retrieved and was retained in patient's ureter. Fda safety report id# (b)(4).
 
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Brand NameNCIRCLE NITINOL TIPLESS STONE EXTRACTOR
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INCORPORATED
MDR Report Key10319990
MDR Text Key200600280
Report NumberMW5095702
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG18778
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number10242147
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/23/2020 Patient Sequence Number: 1
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