• 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-MB
Device Problem Material Separation (1562)
Patient Problem Injury (2348)
Event Date 09/30/2020
Event Type  malfunction  
Manufacturer Narrative
(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
It was reported, during a flexible ureteroscopy (urs), using an ngage nitinol stone extractor, while attempting to remove stone fragments from the kidney, the head of the stone extractor fell off and they couldn't use it. The separated section of the device was retrieved from the patient using a "grasper". A new, same type device was opened and the procedure was successfully completed. It was reported there was an injury, but no details about the injury was provided. Additional information was requested regarding the alleged injury and a response was received advising no additional details could be provided. No section of the device remained inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. No additional patient consequences were reported.
 
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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10654983
MDR Text Key210585855
Report Number1820334-2020-01832
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeHU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-022115-MB
Device Lot Number10332154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2020
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: 10/09/2020 Patient Sequence Number: 1
Treatment
FLEXOR ACCESS SHEATH; OLYMPUS FLEXIBLE URETEROSCOPE
-
-