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

Catalog Number NTSE-022115-UDH

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

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 the ncircle tipless stone extractor was to be used in a transurethral lithotripsy (tul) procedure.The device looked intact prior to opening the package of the device.The user manipulated the device to verify its function prior to use, then noted that basket wires were entangled; two basket wires were entangled and became one x 2, so there were two pair of tangled wires.Since the basket did not open properly, another device was used instead to complete the procedure.As reported, the patient did not experience any adverse effects and the patient outcome is no problems.The device will not be returned due to infectious disease.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.No photograph was provided for review.A search of the north american distribution center (nadc) database shows that all devices from lot number 8997120 have been shipped.No similar product from the same lot is available for investigation.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.A review of the device history record for lot # 8997120 found there were no non-conformances that would have caused or contributed to the reported failure.A review of complaint history records revealed no other complaints have been associated with the complaint device lot number 8997120.The instructions for use (ifu) states the following in consideration of 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.Based on the event information, the basket wires became entangled, preventing the basket from having a symmetric shape, with all 4 wires evenly spaced.Proper basket function, including wire position, is verified multiple times during manufacturing and quality control checks.The device is additionally packaged with the basket open.The information provided indicates the wires crossed after the device was functioned prior to use.It is therefore assumed the basket wires were correct when the device was removed from the package.Without the device, the cause for the crossed wires could not be established.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

No new event information has been received.

• 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: 8285255
• MDR Text Key: 134869018
• Report Number: 1820334-2019-00209
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)210705(10)8997120
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2021
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 8997120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1