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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 Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Event Description
As reported, the basket wire of an ncircle delta wire tipless stone extractor was found broken. This occurred prior to patient contact and the procedure was completed with a new device. There was no impact to the patient due to this occurrence.
 
Manufacturer Narrative
Pma/510(k) #: exempt. (b)(6). A follow up report will be submitted should additional relevant information become available.
 
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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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key12788327
MDR Text Key282337413
Report Number1820334-2021-02473
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002191102
UDI-Public(01)10827002191102(17)240217(10)13763827
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSED-024115-UDH
Device Lot Number13763827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2021
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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