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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
Model Number G32701
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2019
Event Type  malfunction  
Manufacturer Narrative
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 is reported that a distributor found foreign matter sealed inside an compass nitinol tipless stone extractor package. The package was not opened. The device did not make contact with any patient.
 
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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 Key8727988
MDR Text Key148987325
Report Number1820334-2019-01509
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/22/2022
Device Model NumberG32701
Device Catalogue NumberNCT4-024115
Device Lot Number9543999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2019
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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