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

Catalog Number NTSE-015115

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

(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, during a stone removal procedure using a ncircle tipless stone extractor, the basket broke leaving a fragment of wire inside the patient.The stones had been lasered.The extractor device was then used to remove the stones when the basket broke.It took about 1.5 hours to retrieve the wire fragment.It is unknown how the fragment was retrieved or how the procedure was completed.The patient had no further complications.According to the initial reporter, the patient did not experience any adverse effects due to the alleged malfunction.No additional procedures were needed due to the occurrence.Additional information had bee requested.The sale representative informed the manufacturer that the customer would be unable to answer any further questions at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation cook was informed of an incident involving a ncircle tipless stone extractor ntse-015115.The basket of the device reportedly broke, leaving a fragment of wire during a stone removal procedure on (b)(6) 2020.Further communication with the user facility clarified that the wire of the basket broke after the stones were lasered and a fragment of wire was left.The fragment was able to be retrieved, but it took about 1.5 hours to remove.The patient reportedly experienced no additional harm as a result of the issue.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.The complainant returned one ncircle tipless stone extractor.¿ device returned with the handle in the closed position ¿ device returned with the basket formation in the closed position ¿ visual exam notes there is approximately 1 mm of the closed basket formation is protruding the distal end of the basket sheath ¿ mlla [male luer lock adapter] is loose.Collet knob is tight and secure.¿ polyethylene terephthalate tubing [pett] measures 2.8 cm in length.¿ visual exam notes the support sheath is bowed ¿ visual exam notes a kink in the basket sheath 50 cm from the distal tip ¿ function test determines the handle actuates the basket formation ¿ visual exam notes broken wires in the basket formation ¿ visual exam notes discoloration on the broken wires ¿ visual exam notes that fragments of the broken wire were not returned for investigation a review of the device history record could not be conducted due to lack of lot information from the user facility.In response to this incident, cook completed a review of the product dmr.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The product ifu for this device provides the following information to the user: 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 information provided upon review of complaint file, and quality control documents do not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.Most probable cause the damage occurred during the procedure.Conclusion the returned device was found to have a basket that had broken wires, with a section near the distal end missing.The remaining basket wires were severely kinked and discolored, indicating the wires were inadvertently exposed to the laser during the procedure.The risk documentation procedures were reviewed, and it was determined that no actions are required cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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

No new patient or event information since last report.

• 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: 9920620
• MDR Text Key: 197808357
• Report Number: 1820334-2020-00742
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1