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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSED-024115-UDH
Device Problems Component Missing (2306); Out-Of-Box Failure (2311)
Patient Problem No Patient Involvement (2645)
Event Date 02/26/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed. Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
 
Event Description
The complainant reported that one [wire] of the four parts on the basket was missing when the package was opened.
 
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Brand NameNCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7125095
MDR Text Key96008971
Report Number1820334-2017-04112
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002191105
UDI-Public(01)00827002191105(17)171030(10)5402969
Combination Product (y/n)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSED-024115-UDH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2014
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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