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

Catalog Number NCT4-024115

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

It is currently unknown if the complaint device will be returned for investigation.Information has been requested.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, while using a ncompass nitinol tipless stone extractor, the basket broke off at the handle.Additional patient and event information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, while using a ncompass nitinol tipless stone extractor, the basket broke off at the handle during a flexible ureteroscopy with laser lithotripsy.The stone was located in the upper pole calyx in the kidney.The stone was wedged behind the calyx, therefore the added and continuous torque could have caused the breakage.The device was tested prior to use.The working channel size was believed to be a 3.6fr.The handle did not completely separate, rather it was "hanging by a thread".Another basket was opened to finish the procedure.No section of the device remained inside of the patient's body.No additional procedures were required due to this occurrence.No adverse effects were reported due to this occurrence.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examination could be performed.A document-based investigation evaluation was performed.No related non-conformances were recorded, and no additional lot-related complaints were 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.The product specification for the ncompass nitinol tipless stone extractor nct4-024115 was reviewed and all extractors are 100% verified to assure the basket opens and closes properly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which provide the following precautions, ¿precaution: the device is conductive.Avoid contact with any electrified instrument.Precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.¿ the complaint device was not returned, but based on the information provided, it is likely the basket sheath of the device was damaged at the handle during use.Based on the available information, cook has concluded that a cause of the reported event could not be determined.Cook will continue monitoring of similar complaints and has 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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information provided on 16apr2021: the procedure being performed was a flexible ureteroscopy with laser lithotripsy.The stone was located in the upper pole calyx in the kidney.The stone was wedged behind the calyx, therefore the added and continuous torque could have caused the breakage.The device was tested prior to use.The working channel size was believed to be a 3.6fr.The handle did not completely separate, rather it was "hanging by a thread".Another basket was opened to finish the procedure.No section of the device remained inside of the patient's body.No additional procedures were required due to this occurrence.No adverse effects were reported due to this occurrence.

• Brand Name: NCOMPASS NITINOL TIPLESS 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: 11633629
• MDR Text Key: 244449785
• Report Number: 1820334-2021-01094
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 13707764
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 04/16/2021; 05/11/2021
• Supplement Dates FDA Received: 04/21/2021; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS FLEX URETEROSCOPE