Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-017115
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that when the user inspected the device function by opening/ closing the basket prior to use, breakage of the basket wires was confirmed.Another device was used instead.There were no adverse events reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NGAGE NITINOL STONE EXTRACTOR
Type of Device
FFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7133150
MDR Text Key95816135
Report Number1820334-2017-04530
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482944
UDI-Public(01)00827002482944(17)180819(10)6135338
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNGE-017115
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-