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

Catalog Number NTSE-015115

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

(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

It is reported, a ncircle tipless stone extractor was inspected and tested prior to use and found to be functioning properly.During a ureteroscopy lithotripsy (ult) procedure using the device, after using the basket about 5 times to capture stones, the basket wire located at the part inside the purple sheath, broke and separated with the device inside the patient's body.The user stated "i think excessive force was applied to the device".The user removed the black screw at the proximal end of the handle in an attempt to repair the device, but was unsuccessful.The user removed the wire from the endoscope and completed the procedure with a second device.No section of the device detached inside the patient.There were no adverse effects to the patient as a result of this occurrence.

Event Description

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

Manufacturer Narrative

Additional information: section c: investigation ¿ evaluation: event description: it was reported, the basket wire of the device reportedly broke and separated during a ureteroscopy lithotripsy (ult) procedure.Further communication with the user facility clarified that during several times of stone removing, the basket wire (at the part inside the purple protective sheath) broke and separated when the device was in the body.After the separation, the user didn't know what had happened and he removed the black screw at the proximal end of the handle in order to fix the device but the device could not be fixed.The user removed the wire (the other side of the wire with the handle) from the endoscope and another same type device was used to complete the procedure.The patient reportedly experienced no 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, device history record, the instructions for use, manufacturing instructions, and quality control data.One ncircle tipless stone extractor was returned for investigation.The basket sheath measured 114.3cm, and the basket assembly had been pulled out of the basket sheath.The basket formation was attached to the coil assembly, and the length of the basket assembly was 114.2cm.The coil had been severed from the cannulated handle.The unidex handle (udh) was returned separately from the basket sheath.The support sheath was severed at the nose of the mlla (male luer lock adapter).The polyethylene terephthalate tubing [pett] was returned loose from the handle.The cannulated handle measured 15cm, and there were no significant kinks in the basket sheath.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 lot history search found one other complaint had been reported for this lot.It was determined the two complaints were not related and there was no indication of a common failure mode between the two that would indicate a possible issue with the remainder of the devices in the 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.The returned device was found to be significantly damaged.The basket sheath and basket assembly both were broken at the distal end of the handle and were no longer connected to the handle.The clear pett tubing that is normally inside the handle was returned separately, indicating the handle had been disassembled.The provided information stated the issues occurred after several stones had been removed, indicating the device initially functioned properly when used.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.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: 10181339
• MDR Text Key: 196418781
• Report Number: 1820334-2020-01167
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)230218(10)10334925
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2023
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 13015385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS URF-TYPEV2