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

Catalog Number NTSE-015115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The user facility reported during a transurethral lithotripsy procedure, prior to insertion into the patient's body, the physician conducted a functional test of the ncircle tipless stone extractor.The physician found the basket would not open or close when the handle was manipulated.This report is for this first basket.A second device was used but the basket would not open or close either.Se case with manufacturer report number 1820334-2017-04186 for the second device.A third device was used and the procedure was completed without any problems.There were no adverse effects.

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, 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 and the basket formation was in the closed position.The collet knob is tight and secure.The male lure lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.A visual examination noted the basket sheath has five kinks located at 33 cm from the distal tip, again at 45 cm, 53 cm, 103 cm, and 111 cm from the distal tip.The support sheath is bowed in appearance.During an attempt to actuate the basket formation, the basket sheath came out of the handle and is detached.The device history record was reviewed and it was observed there were no non-conformances noted.A review of complaint history revealed this complaint is the only one associated with lot number 8163075.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.Based on the provided information, the root cause cannot 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.

• 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: 7081544
• MDR Text Key: 94198595
• Report Number: 1820334-2017-01477
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)200822(10)8163075
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• 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: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2017
• 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