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

Catalog Number NTSE-015115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(6).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 a transurethral lithotomy (tul), the basket on an ncircle tipless stone extractor was unable to be opened and closed.The device was tested prior to use in the uncoiled position and it functioned properly.The stones were located in the kidney and ureter and upon using the basket with another manufacturers scope "1 or 2 times", it would not open and close.Upon examining the device, the basket was unable to be located so the user disassembled it and found the basket inside the sheath.Another same device was used to complete the procedure.No section of the device remained inside the patient.No additional procedures were conducted due to the occurrence.No adverse events to the patient were reported.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary as reported, during a transurethral lithotomy (tul), the basket on an ncircle tipless stone extractor was unable to be opened and closed.The device was tested prior to use in the uncoiled position and it functioned properly.The stones were located in the kidney and ureter and upon using the basket with another manufacturers scope "1 or 2 times", it would not open and close.Upon examining the device, the basket was unable to be located so the user disassembled it and found the basket inside the sheath.Another same device was used to complete the procedure.No section of the device remained inside the patient.No additional procedures were conducted due to the occurrence.No adverse events to the patient were reported.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.A device failure analysis was conducted on the returned device.The investigator made the following notation: product was returned in open packaging.The device was disassembled and could not be reassembled for examination.The basket does not appear to be in the basket sheeth.Unable to determine cause or recreate failure mode.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows one other complaint associated with the complaint device lot.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complaint device was returned disassembled.It was reported that the user disassembled the device after the failure of the basket to open/close.Although the device was disassembled, it was noted that the basket sheath was separated from the purple support sheath.It was likely that the separation of the basket sheath and support sheath was the cause of the failure of the basket to open/close during use.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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 12934166
• MDR Text Key: 285802315
• Report Number: 1820334-2021-02636
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)241005(10)14255027
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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: 14255027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE