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

Catalog Number NTSE-045065-UDH

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

(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 that the user opened the package for the ncircle tipless stone extractor and found the basket wire to be broken.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also conducted.A review of complaint history, the device history record, instructions for use, and quality control data was performed.One device was returned for investigation.The collet knob and the male luer lock adaptor (mlla) were tight.A functional test noted the handle does not actuate the basket formation.A visual examination noted that one of the basket wires has pulled out of the cannula.There were no kinks or damage noted in the basket sheath.It was noted that the cannulated handle was not in the collet as the collet was not returned.A review of the device history record showed there were no non-conformances related to the reported failure.A complaint history search revealed one additional complaint associated with the complaint device lot number 8322318.The additional complaint is for a different issue and from the same customer as this complaint report.Per the instructions for use (ifu) precaution section: enclose the device in the sheath before removing from the tray/holder.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.The complaint device was found to have a basket wire that pulled free from basket cannula that holds the proximal end of the basket wires.Devices are inspected for damage and functionality prior to packaging, including a pull test.The observed damage likely occurred during handling/use of the device.The returned device was also found to be missing the collet that holds the handle cannula to the handle, causing the basket not to function.The missing collet is very unlikely to be related to the broken basket wire.It is probable the handle of the device was manipulated by the user and disassembled after the broken wire occurred.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 7447369
• MDR Text Key: 106190312
• Report Number: 1820334-2018-01182
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002175204
• UDI-Public: (01)00827002175204(17)201025(10)8322318
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-045065-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1