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

Catalog Number UNKNOWN

Device Problems Material Separation (1562); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510k # exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, a patient had a mid-ureteric stone removed on (b)(6) 2021.Upon examination of the stone that was removed, a piece, the top of an ncircle tipless stone extractor (catalog number unknown) was discovered within/ around the stone.The staff are certain that the basket was lasered during a flexible ureteroscopy and renal stone removal procedure that was performed two years ago, and this piece of the basket had been left in the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

B3: date of event: 2 years ago.Event summary: as reported, a patient had a mid-ureteric stone removed on (b)(6) 2021.Upon examination of the stone that was removed, a piece, the top of an ncircle tipless stone extractor (catalog number unknown) was discovered within/around the stone.The staff are certain that the basket was lasered during a flexible ureteroscopy and renal stone removal procedure that was performed two years ago, and this piece of the basket had been left in the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of quality control data.Investigation of returned device fragment: the distal section of a basket was returned in a specimen cup.Based on the tip formation of the basket, two interlocking loops, it was confirmed the fragment came from a cook ntse extractor device.The exact rpn could not be determined from the fragment.The ends of all 4 wires had a melted and deformed appearance, indicating exposure to a laser.Cook could not complete a review of the device history record (dhr) or search for other complaints from the product lot 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: precautions: these product are intended for use by physicians trained and experienced in urological procedures.Standard urological techniques should be employed.This device is conductive.Avoid contact with any electrified instrument.Enclose the device in the sheath before removing from the tray/holder.Do not use excessive force to manipulate this device.Damage to the device may occur.The returned device fragment showed evidence of laser exposure on all 4 basket wires.Based on the visual inspection of the fragment and information provided by the user, it was determined the basket wires were broken due to laser exposure during a stone removal procedure.The basket fragment was then discovered approximately 2 years later during a subsequent procedure.The cause of the complaint was determined to be a user error.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

• 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: 12233414
• MDR Text Key: 264054883
• Report Number: 1820334-2021-01871
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention