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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NGE-022115-MB
Device Problems Coiled (1098); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 10/23/2017
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
It was reported that the ngage nitinol stone extractor would not uncoil and engage during a urteroscopy with a holmium laser. There were no adverse consequences to the patient as a result of this reported issue. The device did not make contact with the patient.
 
Manufacturer Narrative
Additional information received on 11apr2018: investigation - evaluation: visual inspection and functional testing of the returned device was conducted during the investigation. A review of complaint history, the device history record, instructions for use, quality control data, and specifications was also performed. One device was returned for investigation. The shipping tray was returned; however, the device was not in the shipping tray. The device was returned with the handle in the closed position and the basket formation in a partially opened position. The collet knob is tight and secure. The male luer lock adaptor (mlla) is tight. The polyethylene terephthalate tubing (pett) measures 3. 5 cm in length. A functional test was performed and it was noted that when the basket sheath is in the straight position the handle actuates the basket formation to the fully open and completely closed positions. But, when the basket sheath is coiled the device does not function. A visual examination noted the support sheath is bent 5 mm from nose of the mlla. Also noted, the basket sheath is damaged at the distal end of the support sheath. The device history record was reviewed and found no non-conformances related to the reported failure. A review of complaint history revealed this complaint is the only one associated with complaint device lot number 7737558. The instructions for use (ifu) provides the following information: 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. Devices are inspected for damage and functionality prior to packaging. The complaint device was found to have a non-fully functioning basket due to sheath damage near the handle. Devices are inspected for damage and functionality prior to packaging. The observed damage likely occurred during handling/use of the device. 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.
 
Event Description
The procedure was completed using another ngage nitinol stone extractor.
 
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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 Key7407104
MDR Text Key105302846
Report Number1820334-2018-00962
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 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
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 Received05/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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