• 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-030115-UDH-MB
Device Problems Break (1069); Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 02/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that when the cook district manager received the ncircle tipless stone extractor the handle was not completely in its container. The handle was pushed back into the container and it was noticed that the wire of the basket was also damaged. A visual examination of the sealed package noted the basket formation appears kinked and pulled. An observation of the basket formation noted that one of the wires is severely kinked. Upon the first actuation of the handle, two of the wires broke. No patient involvement.
 
Manufacturer Narrative
Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted. A review of complaint history, the device history record, drawings, quality control data, and specifications was also performed. One unopened package was returned for investigation. A visual examination of the sealed package noted the basket formation appears kinked and pulled. The package was opened for investigation. The collet knob is tight and secure and the male luer lock adapter (mlla) is tight. There was no damage noted to the basket sheath. An observation of the basket formation noted that one of the wires is severely kinked. Upon the first actuation of the handle, two of the basket wires broke 5 mm from the knob. A review of the device history record found no non-conformances related to the reported failure mode. A review for additional complaints for this device lot found revealed this complaint to be the only complaint associated with lot number 8445982. There is no indication that a design or process related failure mode contributed to this event. 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. Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping. Based on the provided information a definitive root cause cannot be established. Per the quality engineering risk assessment, no further action is warranted. Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
 
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
MDR Report Key7312768
MDR Text Key101709433
Report Number1820334-2018-00594
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 company representative
Type of Report Initial,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-030115-UDH-MB
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-