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U.S. Department of Health and Human Services

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

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COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NGE-017115
Device Problems Device Contaminated During Manufacture or Shipping (2969); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
Event Type  malfunction  
Manufacturer Narrative
Reporter occupation: other non-healthcare professional: distributor. 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
As reported, during inspection of products at the user facility a hair was found in the packaging of a ngage nitinol stone extractor. There was no patient involvement.
 
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Brand NameNGAGE NITINOL 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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11628836
MDR Text Key245593594
Report Number1820334-2021-01088
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-017115
Device Lot Number13504459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2020
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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