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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 Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/07/2017
Event Type  Injury  
Manufacturer Narrative
Investigation - evaluation. A review of documentation, drawings, functional testing, manufacturing instructions, specifications, quality control data, and visual inspection of the returned device was conducted during the investigation. The basket formation has been severed from the coil assembly. The complaint was confirmed based on the investigation of returned device. Current controls are in place in manufacturing to assure device functionality 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. There is no indication that a design or process related failure mode contributed to this event. Based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time. 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
It was reported that while performing a bilateral ureteroscopy w/ laser lithotripsy that during the extraction of the stone, when the basket met the ureteral access sheath, the physician went to pull the basket through the access sheath and the tip of the basket broke off. The reporter stated that there was no lithotripsy being used at the time the basket was in use. It was further reported that there was swelling at the uretero pelvic junction, making it difficult to pull the stone into the access sheath. The basket tip was retrieved with a 3 prong grasper. Another basket was used to complete the procedure. No unintended section of the device remained inside of the patient. There were no further adverse effects to the patient from this event.
 
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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 Key7139051
MDR Text Key284965351
Report Number1820334-2017-04344
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,user f
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNTSE-022115-UDH
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
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