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

Catalog Number NTSED-024115-UDH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(4).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 during a ureteroscopy with stone extraction procedure the ncircle delta wire tipless stone extractor would not close.This complaint device was removed and another like device was used.This like device, associated with medwatch 1820334-2018- 00704, presented the same failure.A third like device was used to complete the procedure.The devices were not tested prior to use.There were no adverse consequences to the patient as a result of this reported issue.

Manufacturer Narrative

Evaluation / investigation: a visual inspection and functional testing of the returned devices was conducted.In addition, a review of complaint history, drawings, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications was performed.Two devices were returned, both ntsed-024115-udh lot 8352171x.Device a: the device was returned with the handle in the open position and the basket formation is in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length.A visual examination noted kinks in the basket sheath at 14 cm and 49 cm from the distal tip of the basket sheath.The support sheath is bowed in appearance.A functional test determined the handle actuates the basket formation.With the handle in closed position, 4 mm of the closed basket formation extends beyond the basket sheath.The handle was disassembled.The basket formation could be manually actuated to the open and completely closed positions.The handle was reset and reassembled and with the handle in closed position, the basket formation extends the end of the basket sheath 3 mm.There was no specific complaint reported for this device, as it is believed this is the third device used to complete the procedure after the first two baskets used would not close.Although no issue was reported, it was found that the basket of the device would close, but did extend out of the end of the sheath more than specification allows.The device was found to have a basket that would not fully retract into the sheath, but based on the provided information, the basket functioned well enough to allow the procedure to be completed.Kinks in the sheath were found, the kinks likely prevented the basket from retracting into the sheath.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during use of the device.Device b: actual complaint device: the device was returned with the handle and basket formation in the open position.The collet knob is tight and secure.The mlla is tight.The pett measures 3 cm in length.A visual examination noted the support sheath is severed 3 mm past the nose of the mlla.The remaining support sheath is detached from the basket sheath.A functional test noted the handle does not actuate the basket formation.There were no kinks noted in the basket sheath.The complaint device was found to have a basket that would not close.The support sheath was found to be severed.The separated sheath prevented the handle from actuating the basket.It was reported that the basket of the device would not close during use.Investigation of the returned device found the basket was open and would not close.The device history records were reviewed and no related non-conformances occurred during the production of lot number 8352171x or lot number 8352171.A search of complaint records shows there is a second complaint on the lot number 8352171x.Devices are inspected for damage and functionality prior to packaging.The observed damages likely occurred during use of the device.The instruction for use (ifu) contains multiple cautions about manipulating the device to prevent damage.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.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.Per the quality engineering risk assessment, no further action is warranted.Monitoring 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.

• Brand Name: NCIRCLE DELTA WIRE 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: 7371702
• MDR Text Key: 103548693
• Report Number: 1820334-2018-00703
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)201106(10)8352171X
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSED-024115-UDH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1