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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 Problems Kinked (1339); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation / investigation: the investigation performed included a review of complaint history, the device history record, manufacturing instructions, quality control data, and specifications. A visual inspection of the returned device was also conducted. One device was returned for evaluation. The basket sheath and the coil assembly were returned separated from the unidex (udh) handle. The collet knob is tight and secure. The male luer lock adaptor (mlla) is loose. The polyethylene terephthalate tubing (pett) measures 2. 8 cm in length. It was noted that blood is visible on the handle slide. A visual examination noted the cannulated handle is still inside the udh handle. The cannulated handle is bent at the nose of the mlla and protrudes approximately 1. 8 mm when in the open position. There is 1 cm of support sheath remaining inside the mlla. The support sheath is completely severed. The support sheath has been severed 4. 3 cm from distal and is still adhered to the basket sheath. The length of the basket sheath measures approximately 115. 7 cm. The support sheath and the basket sheath are still adhered. The basket formation does not protrude the basket sheath. Kinks are noted in the basket sheath at 13 cm from the distal tip of the basket sheath, again at 28. 5 cm from the distal tip, and again at 87. 5 cm from the distal tip. There is 22. 7 cm of basket coil protruding from the proximal end of the basket sheath. With the cannulated handle being severed, the actuation of the basket formation could not be checked. It appears that the device met resistance beyond its intended design. 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 and device integrity prior to shipping. 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. The device history record was reviewed and there was one no non-conformance noted for sheath, buckling that could be related to the reported failure mode. The identified product was scrapped. A review of complaints history revealed this is the only complaint received for lot number 7877708. Based on the provided information and the investigation evaluation; a definitive root cause could not be determined. Per the quality engineering risk assessment, no further action is required. Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
 
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
As reported by the user facility, a transureteral lithotripsy (tul) procedure was performed against the stones in the kidney and urinary duct. After the stones were broken, retrieval of the broken fragments was conducted by using a ncircle tipless stone extractor. However, after the physician used it several times, its sheath shaft got kinked and the basket became impossible to open/close. Therefore, another ncircle tipless stone extractor was used. The sheath shaft of this second device also got kinked after it was used several times and the basket became impossible to open/close. A third ncircle tipless stone extractor was used instead and the procedure was completed successfully. As reported, there were no adverse effects to the patient. The physician reports using this product frequently and advised these complaint devices were not used forcibly. The doctor feels the strength of these devices was weaker than usual. Mfr. Report number 1820334-2017-03577 captures the first ncircle tipless stone extractor kinked sheath and mfr. Report number 1820334-2017-03578 captures the second sheath shaft that kinked during this procedure.
 
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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 Key6954040
MDR Text Key266079978
Report Number1820334-2017-03577
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 foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2017
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2017
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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