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

Catalog Number NTSE-022115-UDH

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: postal code: (b)(6).Occupation: theatre manager.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, during a ureteroscopy and removal of ureteric stone using an ncircle tipless stone extractor, the device broke inside of the patient during deployment.The device was tested prior to use.While attempting to retrieve a ureteric stone, one of the wires broke and became detached inside of the patient.This piece was retrieved using another basket.The procedure was completed by using a second basket.The patient did not require any additional procedures due to this occurrence, although the procedure time was extended to retrieve the broken portion of the basket.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Additional information: investigation - evaluation.It was reported, when attempting to retrieve a ureteric stone with the ncircle tipless stone extractor, one of the wires broke and became detached within the patient.This piece was retrieved using another basket.The patient reportedly experienced no additional harm as a result of the issue.Reviews of manufacturing instructions, instructions for use (ifu), and quality control data were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest this device was manufactured out of specification.A review of relevant manufacturing documents was conducted.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: 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 for evaluation.There are multiple possible causes for a broken basket wire.Without the device available, a cause for the broken basket wire could not be determined.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.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.

• 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: 9824591
• MDR Text Key: 183354065
• Report Number: 1820334-2020-00601
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Patient Sequence Number: 1
• Treatment: RIGID URETEROSCOPE 6.5F