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

Catalog Number NTSE-022115-UDH

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/21/2023

Event Type  Injury  

Event Description

As reported, during a transurethral lithotomy (tul), an 'ncircle tipless stone extractors' basket/sheath separated.The stone was located in the renal calyx and was unable to be captured by the basket.The stone was moved to a larger space in renal pelvis and crushed using another manufacturer's ureteroscope and lithotripter, under the unspecified ureteral access sheath.The basket was then used to capture and upon removal of the basket, the device separated and remained inside the patient's body.Per the reporter, the stone was "so large that it became impossible to remove it from the basket".An attempt was made to pull the separated basket/sheath out transurethrally using forceps, but neither the basket nor the stone could be captured.A small incision was made to capture and remove the stone and basket, however the basket containing the stone could not be found and the abdomen was closed.The following day, a ct scan was performed, however the basket containing the stone could not be found.Per the initial reporter, the physician is undecided if additional ct scan will be performed, as if the basket is located, an additional recovery surgery would be necessary, however, the patient is elderly and had an underlying blood-related disease.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer phone = (b)(6).G4 : pma/510(k)# = exempt.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 (annex a).Event summary: as reported, during a transurethral lithotomy (tul), an 'ncircle tipless stone extractors' basket/sheath separated.The stone was located in the renal calyx and was unable to be captured by the basket.The stone was moved to a larger space in renal pelvis and crushed using another manufacturer's ureteroscope and lithotripter, under the unspecified ureteral access sheath.The basket was then used to capture and upon removal of the basket, the device separated and remained inside the patient's body.Per the reporter, the stone was "so large that it became impossible to remove it from the basket".An attempt was made to pull the separated basket/sheath out transurethrally using forceps, but neither the basket nor the stone could be captured.A small incision was made to capture and remove the stone and basket, however the basket containing the stone could not be found and the abdomen was closed.The following day, a ct scan was performed, however the basket containing the stone could not be found.Per the initial reporter, the physician is undecided if additional ct scan will be performed, as if the basket is located, an additional recovery surgery would be necessary, however, the patient is elderly and had an underlying blood-related disease.Investigation ¿ evaluation: reviews of documentation including the review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures as well as a visual inspection and functional test of the device were conducted during the investigation.One ncircle tipless stone extractor was returned in opened packaging.The basket sheath was damaged on the tip and the handle would not actuate the basket formation.The basket wire (the wire that connects the handle to the basket assembly) was stuck inside sheath and could not be pulled free.The qe suggested that the distal tip be cut vertically to see if basket was inside.Due to the size and material, the cut was jagged and splintered, making it impossible to see if the basket was underneath.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did identify one other complaint associated with the reported device lot.The two complaints were not related.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did 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 were nonconforming.Cook also reviewed product labeling.The product ifu, t _ ntse_ rev1, provides the following in relation to the reported failure mode: "precaution: do not use excessive force to manipulate this device.Damage to the device may occur." based on the information provided, inspection of the returned device, and the results of the investigation, the cause of the issue was determined to be procedural related: the stone being moved was too large to then be removed from the basket while still in the kidney.The user then applied enough tensile force to the device to cause the basket to separate.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18377934
• MDR Text Key: 331178123
• Report Number: 1820334-2023-01749
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)260928(10)15679217
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 15679217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• 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: BOSTON SCIENTIFIC LITHOCLAST; NIPRO RIGID URETEROSCOPE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male