• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Occupation
=
non-healthcare professional - clinical resource coordinator. Pma/510(k) number
=
exempt. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that an ncircle tipless stone extractor package was opened and tested prior to use/ patient contact for a ureteroscopy. At the time of testing it was noted that the extractor would not open/close. A new device was opened and used successfully to complete the case. A section of the device did not remain inside the patient¿s body. The patient did not require any additional intervention due to this occurrence. The patient did not experience any adverse effects due to this occurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
8128294891
MDR Report Key12760885
MDR Text Key282100409
Report Number1820334-2021-02448
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002462066
UDI-Public(01)10827002462066(17)240412(10)13887379
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-015115
Device Lot Number13887379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/07/2021 Patient Sequence Number: 1
Treatment
OLYMPUS DIGITAL URETER-RENOSCOPE
-
-