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

Catalog Number NTSE-015115

Device Problems Mechanical Problem (1384); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

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 flexible ureteroscopy stone retrieval case, while using the ncircle tipless stone extractor the purple portion of the sheath (on the handle) broke.The purple portion came out of place.Dislodged but did not separate.The basket was opening and closing prior to this issue.Another of the same device was used to complete the procedure successfully.

Event Description

No new event information to report.

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, manufacturing instructions, quality control data, and specifications.One device returned to manufacturer for investigation.Returned packaging confirms lot number 9324552.The device was returned with the handle in the open position.The basket formation was retracted inside the basket sheath.The male luer lock adapter (mlla) is tight.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.Visual examination noted the support sheath is severed 1 mm past the nose of the mlla.The cannulated handle is bent and severed at 1.7 cm past the mlla.The support sheath and basket sheath are still adhered.There is 2 mm of the coil assembly that protrudes.Functional testing determined the handle does not actuate the basket formation.A review of the device history record for lot 9324552 found there were 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 number 9324552.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.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.The returned device was found to have a basket that was closed and could not be opened due to the basket sheath and basket coil wire having separated from the handle.The separation occurred near the handle.The condition of the returned device makes it possible that it was inadvertently damaged during handling / use.The ifu contains cautions about manipulating the device to prevent damage.The investigation conclusion is cause traced to user; unintended use error caused or contributed to the event.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.

• 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: 8335486
• MDR Text Key: 136033117
• Report Number: 1820334-2019-00370
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)211120(10)9324552
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2021
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9324552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1