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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-022115-UDH
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
One device was returned for investigation. The device was returned with the handle in the open position. The collet knob is tight and secure. The mlla (male luer lock adaptor) is loose. The pett measures 2. 5 cm in length. The handle is severed from the basket sheath and basket assembly. With the handle in the open position, there is 1. 5 cm of cannulated handle protruding from the mlla. The support sheath is severed at the nose of the mlla. The handle actuates the remaining cannulated handle. The proximal end of the basket assembly, 3. 7 cm of the support sheath is still attached. There is 1. 8 cm of the basket sheath protruding from the proximal end of the support sheath. There is 9. 1 cm of the basket coil extending beyond the basket sheath on the proximal end. A visual examination noted kinks in the basket sheath at the following locations; 25. 5 cm from the distal tip of the basket sheath, again at 30 cm, 91 cm, and 101. 5 cm from the distal tip. The basket assembly was removed from the basket sheath, the basket formation was found to be intact and symmetrical. There is a small kink between the distal cannula and the coil assembly. All the pieces of the device have been returned. No patient harm was reported. 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. 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; device integrity prior to shipping. 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. Per the quality engineering risk assessment no further action is required.
 
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
It was reported the ncircle tipless stone extractor's handle disconnected while in use. No adverse effects or consequences were reported to the patient due to this occurrence.
 
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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 Key7147591
MDR Text Key275518534
Report Number1820334-2017-04608
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-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 Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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