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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
Model Number G48294
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 during an unspecified procedure using an ngage nitinol stone extractor, the extractor "didn't work after first attempt" (reference patient identifier (b)(6)). It is unknown how the procedure was completed after this difficulty. Two devices used in this case were returned for evaluation. After further investigation, it was discovered there were two separate failure modes with the two devices returned. For this complaint the device had a basket wire broken. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional details have been requested regarding the patient and event. At this time no additional information has been provided.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8850176
MDR Text Key152950857
Report Number1820334-2019-01886
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482944
UDI-Public(01)00827002482944(17)220408(10)9649637
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,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/08/2022
Device Model NumberG48294
Device Catalogue NumberNGE-017115
Device Lot Number9649637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2019
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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