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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
Model Number N/A
Device Problems Kinked (1339); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/29/2017
Event Type  Injury  
Manufacturer Narrative
Investigation - evaluation: a review of documentation, manufacturing instructions, instructions for use (ifu), device history record, complaint history, visual inspection, specifications, and quality control data was conducted during the investigation. One device was returned for investigation. A functional test was performed and the unidex handle (udh) was found to actuate the basket formation. The collett knob was found to be tight and secure. The support sheath appeared slightly bowed. A visual examination noted the basket sheath is kinked from the distal tip and again from the distal tip. One wire in the basket formation was noted to be cut just below the knot and the other wire is missing. (the other wire was not returned). 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. Additionally, a review of complaint history found no other complaints associated with the complaint device lot number. Based on the provided information a definitive root cause cannot be established or reported at this time. We will notify the appropriate personnel and continue to monitor for similar complaints. Measures have been previously initiated to address this issue. Per the quality engineering risk assessment no further action is required.
 
Manufacturer Narrative
(b)(4). Event is currently under investigation. A follow up report will be send upon conclusion.
 
Event Description
It was reported by the area representative that a patient underwent a percutaneous nephrolithotomy procedure. The device in use was an ncircle tipless stone extractor. The report stated the basket broke during the procedure. A piece of the basket was lodged into the stone and still remains inside the patient¿s kidney. The facility attempted to retrieve the broken piece with a grasper however, the attempt was unsuccessful and a nephrostomy tube was inserted. They were able to extract the remaining stone burden and the small piece of the basket left behind. There was no adverse effects to the patient.
 
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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 Key6522392
MDR Text Key120426161
Report Number1820334-2017-00760
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberNTSE-022115-UDH-MB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/26/2017 Patient Sequence Number: 1
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