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

Catalog Number NTSE-022115-UDH-MB

Device Problem Material Separation (1562)

Patient Problems Extravasation (1842); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Name and address: postal code: (b)(6).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, during retrograde intrarenal surgery (rirs), a ncircle tipless stone extractor became entangled with a stone within the kidney.The user cut the handle of the extractor and removed the basket sheath to release the scope and proceed further.As they removed the sheath a tiny spring-like metal object came out of the basket tip and the user struggled to remove it.The patient then underwent a percutaneous nephrolithonomy (pcnl) procedure where a small sheath was placed and the object was pulled through the sheath and removed from the patient.The device has been discarded by the customer and will not be returned.A "small" extravasation was reported to have occurred.No portion of the device remained inside the patient.No additional patient consequences were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction: d4- this information was incidentally omitted from the initial report.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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

Event summary: as reported, during retrograde intrarenal surgery (rirs), a ncircle tipless stone extractor became entangled with a stone within the kidney.The user cut the handle of the extractor and removed the basket sheath to release the scope and proceed further.As they removed the sheath a tiny spring-like metal object came out of the basket tip and the user struggled to remove it.The patient then underwent a percutaneous nephrolithonomy (pcnl) procedure where a small sheath was placed and the object was pulled through the sheath and removed from the patient.The device has been discarded by the customer and will not be returned.A "small" extravasation was reported to have occurred.No portion of the device remained inside the patient.No additional patient consequences were reported.Investigation - evaluation: reviews of the instructions for use and quality control procedures were conducted during the investigation.No device was returned for investigation.As no lot number was provided, reviews of complaint history or the device history record could not be performed.All extractors have the basket assembly pull tested during assembly.Sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The device is provided with instructions for use which caution, ¿enclose the device in the sheath before removing from the tray/holder,¿ and, ¿do not use excessive force to manipulate this device.Damage to the device may occur.¿ based on the available information, cook has concluded that a cause for the reported difficulty could not be determined.It is possible that procedural factors such as the size/shape/location of the stone and user technique caused the stone to become stuck inside the device basket, then excessive force and/or a laser was used to free the stone, causing the reported damage.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.

• Brand Name: NCIRCLE 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: 12065819
• MDR Text Key: 262476181
• Report Number: 1820334-2021-01603
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH-MB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention