• 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 Problems Loose or Intermittent Connection (1371); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2017
Event Type  malfunction  
Manufacturer Narrative
Corrected information: device available for evaluation changed from "no" to "yes". Investigation ¿ evaluation: a review of the complaint history, the device history record, specifications, and quality control was performed. Visual inspection and functional testing of the returned device was also conducted. One ngage nitinol stone extractor was returned for evaluation. The device was returned with the handle in the closed position and the basket formation partially opened. The collet knob was tight and secure. The male luer lock adaptor (mlla) is finger tight. The polyethylene terephthalate tubing (pett) measures 3. 5 cm in length. A functional test determined the handle does not actuate the basket formation. A visual examination noted the basket sheath is smashed approximately 3mm from the distal tip of the support sheath. The complaint is confirmed. Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event. A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident. A review of the device history record found 1 non-conformance noted for flare broke and the product was scrapped. A review of complaint history found this to be the only reported complaint associated with this product lot number 7505514. Based on the provided information a definitive root cause could not be established. Measures have been initiated to address this failure mode. Per the quality engineering risk assessment, no further action is required. Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
The distributor reported the ngage nitinol stone extractor package was opened in preparation for use in an ureterorenoscopy procedure. Once the device was taken out of the package, the basket was tested by opening and closing it. After testing, the basket would not open again and it was noted that the handle was loose. This stone extractor was not used and it did not make patient contact. The patient did not require any additional procedures 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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6854698
MDR Text Key258726928
Report Number1820334-2017-02864
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-022115-MB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-