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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 Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation: surgical technician. 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, a ncompass nitinol tipless stone extractor was broken inside the package. No patient involvement. Additional information has been requested. At the time of this report, no further information has been provided.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10425941
MDR Text Key203521076
Report Number1820334-2020-01511
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
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNCT4-024115
Device Lot Number13097884
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2020
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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