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

Model Number G46206

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 transurethral lithotripsy (tul) using a ncircle tipless stone extractor, the sheath became kinked.The physician used a laser to break the stone, then attempted to collect the fragments using the ncircle tipless stone extractor.The sheath of the device became kinked after being used once or twice.Therefore, the user had to exchange it with another ncircle tipless stone extractor to complete the procedure.The kink did not have any sharp edges.The patient did not experience any adverse effects as a result of this alleged product malfunction.The patient did not require any additional procedures as a result of this occurrence.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

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.Inspection of the returned device noted the device was returned with the handle in the open position and basket formation was retracted in the basket sheath.The support sheath and basket sheath were severed 1 mm from the male luer lock adapter (mlla).The coil was kinked 1 cm from the mlla and 1.6 cm of the coil assembly was exposed.The basket sheath was kinked 87 cm from the distal tip.Functional testing noted the handle did not actuate the basket formation.The handle was disassembled-the basket formation could be manually actuated by holding the severed pieces of the support sheath together.A visual examination found the basket formation had a broken wire.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.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 production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The returned device was found to be non-functional due to damage near the handle.The purple support sheath and the basket sheath were separated near the handle.The cannulated handle that connects the basket assembly to the handle was also found to be bent.The device appeared to have had an excessive lateral force applied near the handle during use, causing the observed damaged.The ifu contains a caution not to use excessive force to manipulate the device or damage may occur.It was also found that one of the basket wires was broken at the distal end of the basket.The broken wire may have occurred from laser exposure during use, or possibly during handling after the sheath of the device became damaged.Based on the investigation of the returned device, it appears the device was inadvertently damaged during use.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The appropriate internal personnel have been notified and 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.

• 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: 8692519
• MDR Text Key: 147781241
• Report Number: 1820334-2019-01300
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)220327(10)9623186
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2022
• Device Model Number: G46206
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9623186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED FLEXIBLE URETEROSCOPE; UNSPECIFIED FLEXIBLE URETEROSCOPE