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

Catalog Number NTSE-022115-UDH

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: exempt.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 checked the integrity of the ncircle tipless stone extractor before use and found out the basket cannot be retracted.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.In addition, a review of complaint history, the device history record, instructions for use, quality control data, and specifications was performed.One device was returned for investigation.The device was returned with the handle in the closed position.The basket formation was returned in the open position.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 2.6 cm in length.The support sheath and basket sheath are still adhered.There was no damage noted to the basket sheath.A visual examination noted the basket assembly extends 3.7 cm beyond the distal end of the basket sheath.The distal cannula and 2.2 cm of the coil protrudes the distal tip of the basket sheath.It was noted that wires are pulled out of the cannulated handle.A functional test determined the handle does not actuate the basket formation.The device history record was reviewed and noted there were non-conformance issues identified; however, it was not confirmed that any were related to the reported failure mode.A review of complaints history revealed this complaint is the only one associated with this complaint device lot number 6847760.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.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 complaint device was found to have a basket that would not close due to the basket wires being separated from the cannulated handle, preventing the handle from closing the basket.The functioning of the basket would have been tested during manufacturing, quality assurance check, and during packaging.A cause for the observed condition of the returned device could not be determined.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.In addition, a review of complaint history, the device history record, instructions for use, quality control data, and specifications was performed.One device was returned for investigation.The device was returned with the handle in the closed position.The basket formation was returned in the open position.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 2.6 cm in length.The support sheath and basket sheath are still adhered.There was no damage noted to the basket sheath.A visual examination noted the basket assembly extends 3.7 cm beyond the distal end of the basket sheath.The distal cannula and 2.2 cm of the coil protrudes the distal tip of the basket sheath.It was noted that wires are pulled out of the cannulated handle.A functional test determined the handle does not actuate the basket formation.The device history record was reviewed and noted there were non-conformance issues identified; however, it was not confirmed that any were related to the reported failure mode.A review of complaints history revealed this complaint is the only one associated with this complaint device lot number 6847760.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.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 complaint device was found to have a basket that would not close due to the basket wires being separated from the cannulated handle, preventing the handle from closing the basket.The functioning of the basket would have been tested during manufacturing, quality assurance check, and during packaging.A cause for the observed condition of the returned device could not be determined.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: 7484650
• MDR Text Key: 107655507
• Report Number: 1820334-2018-01286
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)190328(10)6847760
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1