• 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 NGAGE NITINOL 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 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NGE-022115
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 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #- 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 ureteroscopy, the basket of an ngage nitinol stone extractor would not fully open or close when attempting to extract a ureteral stone. A new device was used to complete the procedure. 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 NameNGAGE NITINOL 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 Key11300520
MDR Text Key246297353
Report Number1820334-2021-00284
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 Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-022115
Device Lot Number13464060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-