• 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 NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE 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 NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTP-028145
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
Name and address: (b)(4). 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, during a ureteroscopic lithotripsy using a ntrap stone entrapment and extraction device, the tip of the basket could not be advanced, and the basket could not open using the handle. After removing the device, the user cut the wire using scissors and "poked" the tip of the basket out directly with a fine guidewire. The user changed to another new device to complete the procedure. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE
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 Key11046035
MDR Text Key223798809
Report Number1820334-2020-02346
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002327242
UDI-Public(01)10827002327242(17)230317(10)13059033
Combination Product (y/n)N
Reporter Country CodeCN
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
Report Date 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTP-028145
Device Lot Number13059033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-