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

Model Number G46206

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

During a ureteroscopic lithotripsy, the physician attempted to grasp the stone with a ncircle tipless stone extractor, but the sheath that connects to the handle of the device broke.Another ncircle tipless stone extractor was utilized to complete the procedure.No adverse effects to the patient were reported due to this occurrence.No additional procedures were required.No portion of the device remained in the patient after this occurred.

Manufacturer Narrative

Additional information: d10 (concomitant medical products).Investigation/evaluation: 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, 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 returned device noted the device was returned with the handle between the open and closed positions, and the basket formation was in the closed position.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 2.5cm in length.Further visual examination noted the coil was exposed and the coils were in a loop at the point of separation.There was a kink in the basket sheath 1mm from the support sheath.Functional testing determined the handle does not actuate the basket formation.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 1 other complaint associated with the complaint device lot, but the issue was not related to this complaint.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 have a basket that was closed and could not be opened due to sheath damage.The purple support sheath was separated near the handle.The basket coil inside the support sheath was also damaged in the same location.The provided information stated the issue occurred during use.It is most likely that the device was damaged during use due to the handle not being kept in-line with the sheath.Although the support sheath increases the strength of the sheath near the handle, if enough force is applied, the support sheath will become damaged.In this instance the support sheath was damaged enough that it became separated.All devices are inspected for damage and functionality multiple times during manufacturing and quality control checks.The conclusion of the investigation is that excessive force was inadvertently applied to the device, causing the observed sheath damage.The ifu contains a precaution not to apply excessive force to the device, or damage may occur.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 sent on 30sep2019.

• 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: 9134203
• MDR Text Key: 164441369
• Report Number: 1820334-2019-02444
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)220705(10)9857716
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2022
• Device Model Number: G46206
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9857716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: URETEROSCOPE