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

Model Number G46206

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: 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, during an unknown procedure using a ncircle tipless stone extractor, part of the device separated.When removing the device, the basket separated outside of the patient's body.No section of the devices remained in the patient's body.Another manufacturer's device was used to complete the procedure.No adverse effects have been reported due to the alleged malfunction.

Event Description

No additional patient or event information has been received since the last report was submitted.

Manufacturer Narrative

Investigation evaluation: a visual inspection 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, and quality control data.One device was returned for investigation.Inspection of the returned device noted that the device was returned with the handle in the open position.The mlla (male luer lock adapter) was loose and the collet knob was tight and secure.The polyethylene terephthalate tubing (pett) measure 2.7 cm.It was noted that 35.6 cm of the basket sheath was attached to the handle.With the handle in the open position, it was noted that 1.7 cm of the coil assembly protrudes from the end of the basket sheath.The support sheath was partially severed approximately 1 mm from the nose of the mlla.The support sheath was bent at the point of separation.The rest of the device was missing and not returned.A review of the device history record found 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.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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.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 returned device was found to be damaged: the purple support sheath was separated near the handle.The distal end of the sheath had separated and was not returned.35.6 cm of the sheath remained attached to the handle.The original length of the sheath was approximately 115cm.The possible cause for both observed damages is that the device became caught on another device being used in the procedure, and excessive force applied attempting to remove the device caused the sheath to break and support sheath to separate.There is no information provided related to other devices used in the procedure, or that the device was caught during the procedure, so a conclusive determination of the cause could not be determined.Cook could not determine a definitive cause for this complaint.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.

Manufacturer Narrative

Investigation-evaluation: it was concluded that the most likely cause of the sheath damage was use related.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

Additional information was received on 10feb2020: after inserting the device into the scope and using it, the physician repeated inserting the device into the scope and removing it.While doing so, the sheath and the inner wire got separated, and the sheath near the protective purple sheath also got damaged.The part remained in the body was removed.Another ntse-015115 was used instead to complete the procedure.

• 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: 9488482
• MDR Text Key: 175901958
• Report Number: 1820334-2019-03137
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)220221(10)9540841
• 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,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: G46206
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9540841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1