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

Catalog Number NGE-017115-MB

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Name and address: postal code: (b)(6).Pma/510k #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during a flexible ureteroscopy and lithotripsy using a ngage nitinol stone extractor, 10 cm of the tip separated when retracted into the working channel of the ureterorenoscope.The separated tip got stuck in the flexible part of the working channel of the ureterorenoscope.A new scope and basket were used to complete the procedure.The tip was removed from the ureterorenoscope using a brush.The condition of the device was checked and functionality of the device was tested prior to using the device and no defects were found.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Event summary: it was reported, during a flexible ureteroscopy and lithotripsy using a ngage nitinol stone extractor, 10 cm of the tip separated when retracted into the working channel of the ureterorenoscope.The separated tip got stuck in the flexible part of the working channel of the ureterorenoscope.A stone was being withdrawn when the separation occurred.A new scope and basket were used to complete the procedure.The tip was removed from the ureterorenoscope using a brush.The condition of the device was checked and functionality of the device was tested prior to using the device and no defects were found.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, manufacturing instructions, instructions for use (ifu), and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One ngage nitinol stone extractor was returned for investigation with the handle in the open position.The male luer lock adapter (mlla) was tight, and the collet knob was tight and secure.The polyethylene terephthalate tubing measured 3.7cm in length.The basket sheath and support sheath were bent at the nose of the mlla.The basket assembly and a section of the basket sheath were separated 12.1 cm from distal tip.The basket formation was intact.The coil assembly was protruding from the proximal segment 3.4 cm.A function test determined the handle actuates the assembly, even in a bent state.A kink was noted in the proximal segment of the basket sheath 30.5 cm from tip.A document-based investigation evaluation was also performed.No related non-conformances were recorded, and no other lot-related complaints have been received.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions which state, ¿excessive force could damage device.¿ based on the reported information, the basket sheath and basket assembly separated from a tensile force applied when attempting to withdraw the device through the scope.A stone was being withdrawn when the separation occurred.It is likely the stone was too large for the inner diameter of the scope, or the stone/basket became caught on another object, and excessive force was applied in an attempt to withdraw the device.The ifu contains a caution that excessive force could damage the device.Cook has thus concluded that unintended user error likely led to the device separation.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received 02dec2020.A stone was being removed through the scope when the separation occurred.

Manufacturer Narrative

Investigation - evaluation: additional information was received 08jan2021 that the a stone was not being removed through the scope when the device separated.Based on the available information and an evaluation of the complaint device, cook has concluded that it a cause for the device separation could not be determined.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received 08jan2021.A stone was not being removed through the scope when the device separation occurred.

• 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 Key: 10782894
• MDR Text Key: 214800841
• Report Number: 1820334-2020-02003
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482958
• UDI-Public: (01)10827002482958(17)230717(10)13312838
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2023
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 13312838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STORZ FLEXIBLE URETERENSCOPE