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

Catalog Number NTSED-024115-UDH

Device Problems Device Operational Issue (2914); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

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 testing two different ncircle delta wire tipless stone extractors prior to use during a ureteroscopy procedure.While in use during the procedure, neither basket would close properly and the thumb controls were very stiff and difficult to use.A different stone extractor basket was utilized in order to complete the procedure.As reported, there were no adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Evaluation / investigation: the ncircle delta wire tipless stone extractor was not returned.Photographs were not provided.Without the actual device, a physical examination could not be performed.A review of quality control data, and specifications was conducted.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 device history record was unable to be reviewed as the lot number of the complaint device was not provided.Without the device lot number, a complaint history record review for the associated device lot could not be completed.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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6768193
• MDR Text Key: 81852563
• Report Number: 1820334-2017-02169
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/31/2018
• 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