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-022115
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).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
It was reported during a transurethral lithotripsy (tul) procedure, the physician opened the package of the ngage nitinol stone extractor and conducted a functional check prior to use.Although the handle was manipulated, the opened basket (this product is originally packed/shipped to the customer with its basket opened) could not be closed.Another ngage nitinol stone extractor from the same lot# was used instead without problems.There were no adverse effects to the patient.
 
Manufacturer Narrative
Investigation ¿ evaluation: visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, quality control data, and specifications.One device was returned for investigation.A functional test determined the handle does not actuate the basket formation.A visual examination noted the support sheath and the basket sheath are detached.A review of the device history record found there were no non-conformances associated with the complaint device lot number.A complaint history search revealed this complaint is the only one associated with lot number 8661856.Per the instructions for use (ifu): caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complaint device was found to have a basket that would not close due to the support tube and sheath having separated from the handle.With the sheath separated from the handle, the motion of the handle could not be transferred to the basket to close it.Devices are inspected for damage and functionality prior to packaging.The ifu contains cautions about manipulating the device to prevent damage.The likely cause for this issue was product use or handling related - product received excessive pressure.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
 
Event Description
It was reported during a transurethral lithotripsy (tul) procedure, the physician opened the package of the ngage nitinol stone extractor and conducted a functional check prior to use.Although the handle was manipulated, the opened basket (this product is originally packed/shipped to the customer with its basket opened) could not be closed.Another ngage nitinol stone extractor from the same lot# was used instead without problems.There were no adverse effects to the patient.
 
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
MDR Report Key7659611
MDR Text Key113193819
Report Number1820334-2018-02027
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002482975
UDI-Public(01)00827002482975(17)210313(10)8661856
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/13/2021
Device Catalogue NumberNGE-022115
Device Lot Number8661856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Date Manufacturer Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-