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

Catalog Number NTSE-022115-UDH

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

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 ureteroscopic stone retrieval procedure, the ncircle tipless stone extractor broke.It appeared the stone extractor flipped and broke.The part of the basket that catches the stone broke off in the ureter and was retrieved without any patient harm.No adverse effects or consequences were reported to the patient due to this occurrence.Additional information has been requested from the customer.

Manufacturer Narrative

Investigation ¿ evaluation: the ncircle tipless stone extractor was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of documentation, manufacturing instructions and quality control data was conducted.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record was not able to be performed as the device lot number was not provided.A review for additional complaints for this device lot was also not able to be completed without the device lot number.Based on the provided information a definitive root cause could not be established.Measures have been initiated to address the reported failure mode.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 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: 7066453
• MDR Text Key: 93178173
• Report Number: 1820334-2017-04182
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR