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

Catalog Number NTSED-024115-UDH

Device Problem Break (1069)

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

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

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 an unknown procedure, the ncircle delta wire tipless stone extractor "broke".No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b3, b5, d11, and e4.Investigation ¿ evaluation: it was reported, the basket of the device would not close during a cystoscopy stone extraction in the kidney.Another basket was used to complete the procedure.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, manufacturing instructions, the instructions for use, and quality control data.One device was returned for investigation.Inspection of the returned device noted: the device was returned with the handle in the open position, the basket formation was partially open, the mlla [male luer lock adapter] was finger tight , the collet knob was tight and secure, 3 mm of the basket formation was protruding the distal end of the basket sheath, kinks were found in the basket sheath located 42.8 cm from the distal end of the basket sheath and again at 91.5 cm from distal end of basket sheath, the support sheath was severed approximately 1 mm from the nose of the mlla, the remaining section of the support sheath and basket sheath were still adhered, part of the cannulated handle and the coil assembly were exposed 1 cm, and the coil assembly was bent at distal end of cannulated handle.Functional testing determined the handle did not actuate the basket formation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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 returned device was found to have a basket that was closed and could not be opened due to sheath damage.The basket sheath and yellow support sheath were both separated near the device handle.The separated sheaths prevented the motion of the handle from opening the basket.The provided information stated the issue occurred during use of the device.Devices are inspected for damage and functionality multiple times during manufacturing and quality control inspections.The device was also packaged with the basket in the open position, indicating the device was not damaged when received by the customer.It is possible that the device was damaged during use due to procedural factors such as the size, shape, or location of the stones, user technique, or interaction with another device such as the scope.There is no information provided related to procedural issues, therefore the definitive cause for the issue 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.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

Additional information was received 12mar2020: it was reported, the procedure being performed was a cystoscopy stone extraction in the kidney.The device was tested prior to use, there was no mention of an issue with the device.The basket was deployed and would not retract.A different basket was used to complete the procedure.Patient demographics are not available.No unintended section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.

• Brand Name: NCIRCLE DELTA WIRE 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: 9773974
• MDR Text Key: 183528536
• Report Number: 1820334-2020-00511
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)221204(10)10190432
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 10190432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXIBLE URETEROSCOPE 3.6FR