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

Catalog Number NTSED-024115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

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 stone extraction procedure, upon opening the ncircle delta wire tipless stone extractor, the basket would not open and close.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Evaluation / investigation: a visual inspection and functional testing of the two returned devices was conducted.In addition, a review of complaint history, the device history record, drawings, manufacturing instructions, quality control data, and specifications was performed.Device a: the device was returned with the handle in the closed position.The basket formation was in the closed position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 3 cm in length.There were no kinks in the basket sheath.A functional test determined the handle actuates the basket formation.A visual examination of the returned device noted the basket formation has one wire that has been broken/cut.Device b: the device was returned with the handle in the closed position and the basket formation is in the closed position.The collet knob is tight and secure.The mlla is loose.The pett measures 3 cm in length.There were no kinks in the basket sheath.A functional test determined the handle actuates the basket formation.A visual examination of the returned device noted the basket formation has one wire that has been broken/cut.The device history record was reviewed and noted there were no non-conformance issues.A review of complaints history revealed this complaint to be one of two complaints associated with lot 8231417.The other complaint is from the same customer but for a different failure mode.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.Based on the provided information and the investigation evaluation; a definitive root cause could not be determined.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 DELTA WIRE 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: 7132678
• MDR Text Key: 95946933
• Report Number: 1820334-2017-04189
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)200920(10)8231417
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSED-024115-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1