• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSE-015115
Device Problems Kinked (1339); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, the device history record, documentation, instructions for use, quality control data and specifications was conducted. 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. 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. The device history record was reviewed and noted that three (3) non-conformance issues were identified. The non-conformances included, the basket/grasper will not open/close, loose foreign matter and a displaced component inside the package. A review of complaint history revealed there have been two other complaints associated with complaint device lot number 7872052. 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 for the reported issue 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.
 
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
As reported by the user facility, a transuretheral lithotripsy (tul) procedure was performed against the stones in the kidney and urinary duct. After the stones were broken, retrieval of the broken fragments was conducted by using a ncircle tipless stone extractor. However, after the physician used it several times, its sheath shaft got kinked and the basket became impossible to open/close. Therefore, another ncircle tipless stone extractor was used. The sheath shaft of this second device also got kinked after it was used several times and the basket became impossible to open/close. A third ncircle tipless stone extractor was used instead and the procedure was completed successfully. As reported, there were no adverse effects to the patient. The physician reports using this product frequently and advised these complaint devices were not used forcibly. The doctor feels the strength of these devices was weaker than usual. Mfr. Report number 1820334-2017-03577 captures the first ncircle tipless stone extractor kinked sheath and this report captures the second sheath shaft that kinked during this procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNCIRCLE TIPLESS STONE EXTRACTOR
Type of DeviceFFL 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 Key6954041
MDR Text Key265193403
Report Number1820334-2017-03578
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-015115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-