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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 Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4). 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 the ncircle tipless stone extractor not working properly during ureterolithotripsy. The extractor was broken; dismantled, as informed by the customer. 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.
 
Manufacturer Narrative
Investigation ¿ evaluation: visual inspection and functional testing of the returned device was conducted. A document based investigation was also performed. This included a review of complaint history, the device history record, instructions for use, and quality control data. One device was returned for investigation. The device was returned with the handle and the basket formation in the open positions. The collet knob is tight and secure. The male luer lock adapter (mlla) is loose. The polyethylene terephthalate tubing (pett) measures 3 cm in length. A functional test determined the handle does not actuate the basket formation. The basket sheath has a kink at 89 cm from the distal tip of the basket sheath. A visual examination noted the basket formation appears flat with 2 wires appearing crossed. The handle was disassembled. The basket formation cannot be manually actuated. The basket formation is asymmetrical in appearance. The returned device was found to have a basket that would not function, and the basket was collapsed. The device was not dismantled in any way. A review of the device history record found there were no non-conformances related to the reported failure mode. A complaint history search revealed on additional complaint associated with lot number 7944524 for a similar issue from the same customer. Per the instructions for use (ifu), precaution 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 complaint device was found to have a basket that would not function due to sheath damage. The sheath was found to be kinked. When the device was disassembled the basket could not be moved within the kinked sheath. It was also observed the basket wires were not in the proper shape. The kinked sheath and deformed basket wires indicate the device was damaged during use. Devices are inspected for damage and functionality prior to packaging. The observed damage likely occurred during handling/use of the device. The ifu contains cautions about manipulating the device to prevent damage. The likely cause for this issue was product use or handling related - product received excessive pressure. 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.
 
Event Description
It was reported that the ncircle tipless stone extractor not working properly during ureterolithotripsy. The extractor was broken; dismantled, as informed by the customer. 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.
 
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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
MDR Report Key7582151
MDR Text Key110474767
Report Number1820334-2018-01684
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,foreig
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/25/2020
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number7944524
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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