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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCOMPASS NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NCOMPASS NITINOL TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NCT4-024115
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation: operating theater nurse manager. Pma/510k # ¿ exempt. 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 reported, prior to the start of a ureteroscopy in the kidney, using a ncompass nitinol tipless stone extractor, the scrub nurse noticed the stone extractor shaft located above the handle was kinked. A new stone extractor was opened to continue the procedure. The issue with this device was discovered prior to making contact with the patient and it was not used. No adverse events have been reported as a result of the alleged malfunction.
 
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Brand NameNCOMPASS NITINOL 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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10038277
MDR Text Key199990131
Report Number1820334-2020-00923
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002327013
UDI-Public(01)10827002327013(17)210319(10)8672970
Combination Product (y/n)N
Reporter Country CodeMY
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 06/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/19/2021
Device Catalogue NumberNCT4-024115
Device Lot Number8672970
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2018
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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