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

Model Number G46206

Device Problem Detachment of Device or Device Component (2907)

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

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 is reported during a ureteroscopy /stone manipulation using a ncircle tipless stone extractor, the wire inside that makes the extractor open and close broke during the case.It is unknown how the procedure was completed.No adverse effects to the patient have been reported as a result of this alleged product malfunction.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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(ifu), manufacturing instructions, and quality control data.One device was returned to the manufacturer for investigation.The returned packaging confirms the lot number.The device was returned with the handle in the open position and the basket formation retracted in the basket sheath.The mlla [male luer lock adapter] was loose.The collet knob was tight and secure.A visual examination notes: several kinks in the basket sheath, the support sheath and basket sheath were severed 1 mm from the mlla, and 5 cm of the coil is exposed.The basket formation was found intact and not damaged.Functional testing determined the handle does not actuates the basket formation.A review of the device history record found no non-conformance's related to the reported failure mode.A review of complaint history revealed no additional complaints associated with the complaint device lot.The 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.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Conclusion: the returned device was found to be non-functional due to sheath damage.The purple support sheath and basket sheath were both separated near the handle.The cannulated handle that connects the basket to the handle was also found to be bent.The device appeared to have had excessive force applied to the sheath near the handle during use.A lateral force applied to the device near the handle could have damaged the sheath and bent the cannulated handle.The ifu contains a caution not to use excessive force to manipulate the device or damage may occur.Based on the evaluation of the returned device, the likely cause for the issue was that excessive force was inadvertently applied to the device during use.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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

Additional information was provided on (b)(6) 2019: an unspecified laser was used during the case.The device was tested prior to use.The wire inside that makes the basket open and close broke but did not separate from the device.The procedure was completed with a second tipless stone extractor.There was nothing with the patient's anatomy that prevented the basket from opening or closing properly.

• 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: 8677289
• MDR Text Key: 147521163
• Report Number: 1820334-2019-01273
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)220219(10)9534488
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: G46206
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9534488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1