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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR

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COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR Back to Search Results
Catalog Number NTSED-024115-UDH
Device Problems Loose or Intermittent Connection (1371); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/21/2016
Event Type  malfunction  
Manufacturer Narrative
Additional information: common device name: ffl (field would not populate due to technical problem). This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that the basket of the first device was loosely attached at the distal end and would not open properly. The second basket was also loosely attached at the distal end, but it would not close completely after opening. The urologist was able to complete the procedure with the second basket, but this problem led to additional procedure time. A visual examination also noted one of the basket wires on one of the devices was cut. No pieces of the devices were left in the patient, and there were no injuries or additional procedures.
 
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Brand NameNCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7122899
MDR Text Key95738339
Report Number1820334-2017-04125
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2017
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 Manufactured03/25/2016
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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