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U.S. Department of Health and Human Services

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

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COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSE-015115
Device Problem Difficult to Open or Close (2921)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable. Name and address: phone: (b)(6). Name and address: postal code: (b)(6). Occupation: (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
As reported, while testing a ncircle tipless stone extractor prior to use in a procedure, the basket formation did not fully open. The patient was under sedation for an extra ten minutes while the device was replace with another of the same type. The procedure was completed successfully. No unintended section of the device remained inside of the patient's body. No additional procedures were required due to the occurrence. No adverse effects were reported due to the alleged malfunction. Additional patient and event information has been requested.
 
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Brand NameNCIRCLE 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 Key11345330
MDR Text Key245762384
Report Number1820334-2021-00352
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup
Report Date 05/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-015115
Device Lot Number13469067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2020
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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