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Catalog Number NTSE-030115-UDH
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2018
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
The nurse has opened the sterile package and tried to test the ncircle tipless stone extractor basket, it could not open (basket not active). The device was not used on the patient. No additional procedures were required and there were no adverse effects on the patient due to this occurrence.
Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection and functional testing of the returned devices was conducted. A document based investigation was also performed. This included a review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications. Two devices were returned for investigation. Device a: the device was returned with the handle and basket formation in the open position. The male luer lock adapter (mlla) is missing from the stone extractor and was not returned. The collet knob is loose. The polyethylene terephthalate tubing (pett) measures 1. 5 cm in length. A functional test determined the handle does not actuate the basket formation. A visual examination noted the basket formation is asymmetrical. There are kinks noted in the basket sheath at 53 cm and 61 cm from the distal end of the basket sheath. A kink was noted in the support sheath 3 cm from the distal tip. The basket formation cannot be manually actuated. The basket assembly appears to be stuck in the basket sheath. Device b: the device was returned with the handle in the open position. The basket formation is in the closed position. The collet knob is tight and secure. The mlla is tight. The pett measures 2. 7 cm in length. A functional test noted the handle does not actuate the basket formation. A visual examination noted the support sheath is bowed in appearance. The basket formation is smashed 5mm to 1 cm from the distal tip. It was noted the basket sheath has been scraped along the length. The handle was disassembled. The support sheath and basket sheath were found to be detached; glue was found on the basket sheath where the support sheath should be located. The basket formation can be manually actuated. A review of the device history record found there were no non-conformances that may have contributed to this event. A complaint history search revealed one similar complaint associated with the complaint device lot number ns7134996. After they opened the product package, they found that tip of handle can't be moved. Per the instructions for use (ifu) precaution section: enclose the device in the sheath before removing from the tray/holder. Do not use excessive force to manipulate this device. Damage to the device may occur. 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 devices were found to have a basket that was closed and could not be opened due to sheath damage. For device a: multiple kinks were found along the length of the sheath. The basket could not be manually actuated with the handle removed, indicating the coil assembly was stuck inside the damaged sheath and was not free to move. For device b: the support tube was found to be bowed, the basket formation was damaged, and the basket sheath was scrapped along its length. It was also found that the support sheath and basket sheath were separated, with proper glue residue noted. All devices are inspected for functionality and damage prior to packaging and are packaged with the basket open. The condition of the returned devices makes it likely that they were inadvertently damaged when removing them from the package, or during subsequent handling. The ifu contains cautions about manipulating the device to prevent damage. The conclusion was determined to be traced to the user; unintended user error caused or contributed to event. 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
No additional event information has been received since the last report submission on 03jul2018.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key7659770
MDR Text Key113188882
Report Number1820334-2018-01990
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeTH
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 08/06/2018
1 Device was Involved in the Event
0 Patients were 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
Device Expiration Date07/20/2019
Device Catalogue NumberNTSE-030115-UDH
Device Lot NumberNS7134996
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial