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

Catalog Number NTSE-015115

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2018

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 the ncircle tipless stone extractor basket was unable to open or close.An alternative device from a different lot used to complete the procedure as intended.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

Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the open position.The basket formation is in the open position.The polyethylene terephthalate tubing (pett) was not returned with the handle.The collet knob is loose.The male luer lock adaptor (mlla) is finger tight.A functional test noted the handle does not actuate the basket formation.The handle was disassembled.The basket formation could be manually actuated.The support sheath and basket sheath are still attached.There were no kinks noted in the basket sheath.The handle was reassembled using a different pett to test basket actuation.The reassembled handle allowed the basket formation to function properly.The missing pett, prevented the device from functioning properly.It is unclear what happened to the pett.A review of the device history record revealed no non-conformances associated with the complaint device lot number.A review of complaint history for this device lot revealed one other complaint associated with lot number 8526101.The complaint is for an unrelated failure mode from a different customer.As 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 non-functioning basket due to handle issues.As received, the basket handle was missing the pett tube and the pinch vise was loose in the returned tray.Devices are inspected for damage and functionality prior to packaging.It is likely the handle became disassembled after packaging.Either the collet knob was loose and allowed the internal components of the handle to fall out, then the collet knob was reinstalled by the user.Or the device was manipulated by the user, causing the collet knob to come loose, causing the internal components to fall out.The collet knob is torqued into place using a torque driver during assembly.Devices are also inspected for damage and functionality prior to packaging.The cause for the collet knob becoming separated from the handle could not be determined.It is unclear what happened to the pett.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.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7369661
• MDR Text Key: 103548545
• Report Number: 1820334-2018-00480
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)210122(10)8526101
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1