• 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 DELTA WIRE 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 DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSED-024115-UDH
Device Problems Loose or Intermittent Connection (1371); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation / investigation: a review of complaint history, the device history record, quality control data, and specifications was performed. A visual inspection and functional testing was also conducted. One device was returned for investigation. The device was returned with the handle in the open position. The collet knob was tight and secure. The male luer lock adaptor (mlla) was tight. The polyethylene terephthalate tubing (pett) measures 3 cm in length. A functional test determined the handle does not actuate the basket formation. The support sheath and basket sheath are still adhered. A visual examination noted the basket sheath is smashed starting at the distal tip and extending to 1. 5 cm from the tip of the basket sheath. The smashed tip most likely has contributed to the device not functioning correctly. The complaint is confirmed. 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 reviewed and one non-conformance was noted. The non-conformance was related to a label, applied incorrectly. A review of complaints revealed this complaint to be the only reported complaint associated to the complaint lot number 7601031. 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.
 
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 distributor reported the ncircle delta wire tipless stone extractor was opened in preparation for use in an ureterorenoscopy procedure. Once it was taken out of the package, the basket was tested by opening and closing it. Then, the basket would not open again and it was noted that the handle was loose. This stone extractor was not used. It did not make patient contact. The patient did not require any additional procedures due to this occurrence. The patient did not experience any adverse effects due to this occurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNCIRCLE DELTA WIRE 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 Key6853325
MDR Text Key262259239
Report Number1820334-2017-02863
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 distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSED-024115-UDH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-