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U.S. Department of Health and Human Services

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

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COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSE-015115
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2017
Event Type  malfunction  
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 transurethral ureter-lithotripsy procedure, the physician conducted a functional check of the ncircle tipless stone extractor prior to insertion of the patient's body and discovered that the basket could not open or close.Another stone extractor was used to complete the procedure successfully.No adverse effects or consequences were reported to the patient due to this occurrence.
 
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, manufacturing instructions, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the open position and the basket formation also in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length and was returned on the outside of the cannulated handle.When the handle was actuated, the support sheath and the basket sheath were found to be separated.There is minimal adhesive on the basket formation.No damage was noted on the basket sheath.The basket assembly can be manually actuated.The device history record was reviewed and noted two non-conformances were identified.One issue was related to component, missing and the second issue basket/grasper will not open/close.A review of complaint history revealed this is the only complaint associated with lot number 8164308.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 and device integrity prior to shipping.Based on the provided information a definitive root cause cannot be established at this time.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.
 
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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 Key7067483
MDR Text Key93459736
Report Number1820334-2017-04184
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002462069
UDI-Public(01)00827002462069(17)200823(10)8164308
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNTSE-015115
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/15/2017
Initial Date FDA Received11/29/2017
Supplement Dates Manufacturer Received01/25/2018
Supplement Dates FDA Received02/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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