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

Model Number G17627

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

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 that during a trans-ureteral lithotripsy, a ncircle tipless stone extractor was inserted in a ureteroscope "when a fray on the sheath" was found 1 cm from the blue protective sheath.After this fray was discovered "they continued using the device." the user was able to "capture" the stone with the basket, but found that the basket stopped actuating.The user then used "force" to slide the lever, but broke a wire.The device then became stuck within the patient's body, so the operator then disassembled the handle and pulled the wire from the proximal tip of the handle, which caused the stone to be released from the basket.The operator was then able to remove the device from the patient's body.Another ncircle tipless stone extractor was used to complete the procedure.No adverse effects to the patient were reported to have occurred due to this event.

Manufacturer Narrative

Additional information: d10 (concomitant medical products).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.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the device noted the device was returned with the handle in the open position, and the basket formation was retracted in the basket sheath.The mlla (male luer lock adapter) was loose, the collet knob was not returned, and the polyethylene terephthalate tubing [pett] measured approximately 3 cm in length.Further visual examination noted 11cm of the cannulated handle protruded from the distal end of the white handle.A 5mm loop of coil was sticking out of the handle slide, and the basket sheath is severed 3mm from the distal end of the support sheath.The basket sheath was stretched and pulled beginning 4cm from the distal tip and extending to 12cm from the distal end.The coil wire and braiding was frayed within the stretched and pulled section of the basket sheath.A review of the device history record 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 no other complaints 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 returned device was found to be inoperable due to extensive damage.Damage was noted to the basket sheath, the cannulated handle, and the handle was disassembled.From the information provided, the user originally noted the basket sheath was damaged near the blue support sheath.The damage then caused the basket to become inoperable.The user then attempted to disassemble the device to remove the device from the scope.It is likely the original issue was damage to the basket near the support sheath, and that the other issues noted with the device were as a result of that initial damage to the basket sheath.The basket sheath appears to have buckled due to compressive forces applied during use.As the basket is functioned, the basket coil moves within the basket sheath to open and close the basket.Friction between the basket coil and basket sheath creates a force that compresses the basket sheath when closing the basket.If the device is in a tortuous or semi-tortuous path, the compressive force increases.If the force is great enough, it can cause the sheath to buckle near the handle, where the force is the greatest.The path of the scope / device during use, and the size and location of the stone are unknown, therefore it could not be confirmed that the cause of the issue was related to a tortuous device path.Most probable cause cannot be determined, but it appears the device may have been damaged during the procedure.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.

Event Description

No new patient or event information since the last report was submitted on 25sep2019.

• 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: 9119931
• MDR Text Key: 176456352
• Report Number: 1820334-2019-02414
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002176270
• UDI-Public: (01)00827002176270(17)211022(10)9251803
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: G17627
• Device Catalogue Number: NTSE-030115-UDH
• Device Lot Number: 9251803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1