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

Catalog Number NTSE-045065-UDH

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Name and address: phone: (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

It was reported that during a ureteroscopic lithotripsy procedure, the basket wires of an ncircle tipless stone extractor broke.A new device was used to complete the procedure.The patient did not experience any harm as a result of the issue.Additional information has been requested regarding the patient and the event.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.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.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 was received 22dec2020: one of the wires broke when the stone was caught under the endoscope.The wire is broken at the root.Additional information was received on 24dec2020: the hospital disinfected the device, it was used on different patients.The broken part of the basket was removed, but no additional procedure was required.Additional information was received 29dec2020: a wire did separate from the device.It is unknown how the separated wire was removed from the patient.

Manufacturer Narrative

Event summary: it was reported that during a ureteroscopic lithotripsy procedure, the basket wires of an ncircle tipless stone extractor broke from the device when the stone was caught under the endoscope.The hospital disinfected the device and used it on multiple patients.One of the wires separated from the device.The broken part of the basket was removed, but no additional procedure was required.A new device was used to complete the procedure.The patient did not experience any harm as a result of the issue.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 was performed.A document-based investigation evaluation was performed.No related nonconformances 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 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.¿ the ifu further states, "intended for one-time use.Sterile if package is unopened or undamaged.Do not use product if there is doubt as to whether the product is sterile." the provided information stated that one of the basket wires broke when the stone was caught under the endoscope.Based on that information, it was likely the basket wire broke from the force applied to withdraw the device while the stone was caught in place.Information was also provided that the device was reused.Cook has thus concluded that the cause for the issue was a user error, as excessive force was applied to the device contrary to the information in the instructions for use.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

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: 11058364
• MDR Text Key: 223382026
• Report Number: 1820334-2020-02355
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002175201
• UDI-Public: (01)10827002175201(17)230410(10)13126561
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2023
• Device Catalogue Number: NTSE-045065-UDH
• Device Lot Number: 13126561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 47 YR