• 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 Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma/510(k) #: exempt. 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 two ncircle tipless stone extractors were kinked on the tip. A third extractor was used but was kinked on the shaft (please refer to mdr #1820334-2018-01196). They were all difficult to close after kinking. The user had to use a fourth basket to successfully complete the procedure. The glass tip of both laser fibers broke off in the scope. They had to use a third fiber to successfully complete the procedure. (b)(4) - 2 ncircle tipless stone extractor - mdr #1820334-2018-01195, (b)(4) - 1 ncircle tipless stone extractor - mdr #1820334-2018-01196, (b)(4) - 2 cook® single-use holmium laser fiber - mdr# 1820334-2018- 01197. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Event Description
Event occurred during a ureteroscopy with laser lithotripsy procedure. (b)(4) - 1 ngage nitinol stone extractor ¿ mdr #1820334-2018-01196.
 
Manufacturer Narrative
Additional information & correction. Evaluation / investigation: a visual inspection and functional testing of the returned devices was conducted. A review of the instructions for use, quality control data, and specifications was also performed. Two devices were returned for investigation. Device a: the device was returned with the handle between the open and closed position. The basket formation was partially open, extending the basket sheath 5 mm. The collet knob is tight and secure. The male luer lock adaptor (mlla) is tight. The polyethylene terephthalate tubing (pett) measures 2. 5 cm in length. A visual examination noted kinks in the basket sheath at the distal tip and again at 48 cm, 65 cm, 87 cm, 87. 5 cm, 88. 5cm, and 89 cm from the distal tip of the basket sheath. A functional test was performed and the handle actuates the basket formation to the open and closed position. Device b: the device was returned with the handle between the open and closed position. The basket formation was partially open, extending the basket sheath 5 mm. The collet knob is tight and secure. The mlla is tight. The pett measures 2. 5 cm in length. A visual examination noted kinks in the basket sheath starting at 71 cm from the distal tip and again at 88. 5 cm, 89 cm, and 89. 5 cm from the distal tip of the basket sheath. The support sheath was noted to be bowed starting at 1 cm from the mlla. A functional test was performed and the handle actuates the basket formation to the open and closed position. The device history records were not able to be reviewed as the lot number of the complaint devices was not provided. A review of complaint history for the associated device lot could not be performed without the complaint device lot number. As documented in the instructions for use (ifu), precautions section: enclose the device in the sheath before removing from the tray/holder. Do not use excessive force to manipulate this device. Damage to the device may occur. A review of relevant manufacturing documents was conducted. It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted. The sheaths of both devices were found to have multiple kinks along the length of the sheath. Based on the nature of the kinks, it appears there were issues attempting to insert the devices into the scope during the procedure. The returned ngage nitinol stone extractor (mfr report #1820334-2018-01196) also used during the same procedure had similar kinks in the sheath. Three devices with similar damage during the same procedure indicates there was possibly an issue with the scope that made insertion of the sheaths difficult. 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 Key7480765
MDR Text Key107246031
Report Number1820334-2018-01195
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,user f
Type of Report Initial,Followup
Report Date 05/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-