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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED NGAGE DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INCORPORATED NGAGE DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number G48294
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2020
Event Type  malfunction  
Event Description
Malfunction - doesn't close all the way.
 
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Brand NameNGAGE
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key10004728
MDR Text Key189171723
Report Number10004728
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482944
UDI-Public(01)00827002482944
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG48294
Device Catalogue NumberNGE-017115
Device Lot Number10013260
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2020
Event Location Hospital
Date Report to Manufacturer04/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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