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

MAUDE Adverse Event Report: COOK MEDICAL NCIRCLE NITINOL TIPLESS STONE EXTRACTOR 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 MEDICAL NCIRCLE NITINOL TIPLESS STONE EXTRACTOR DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number NTSE-022115-UDH
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/26/2022
Event Type  Injury  
Event Description
Physician attempted to remove the ncircle basket with a kidney stone in it. He tugged at it and the tip of the basket broke off in the right ureter. He then proceeded to attempt to retrieve the basket with two other baskets, unsuccessfully. Pt retained the basket and stone in the right ureter. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNCIRCLE NITINOL TIPLESS STONE EXTRACTOR
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK MEDICAL
MDR Report Key14676923
MDR Text Key293960565
Report NumberMW5110277
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician Assistant
Type of Report Initial
Report Date 06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNTSE-022115-UDH
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number14650212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/10/2022 Patient Sequence Number: 1
-
-