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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 Break (1069); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the complaint history, device history record, quality control, specifications, and visual inspection of the returned device were conducted during the investigation. The physical evaluation of the device that was returned and it confirmed that the basket sheath was separated from the coil assembly. 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. A review of the device history record found 1 other non-conformance associated with the complaint device lot number 7756322 (difficult to advance thru sheath ). Based on the investigation, 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. Additionally, a review of records found this complaint to be one of two complaints associated with lot 7756322. (b)(4) was for the same lot number, but the failure mode was different. Based on the provided information a definitive root cause cannot be established or reported at this time. 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 that during an intended transurethral stone removal procedure, the physician inserted an ncircle tipless stone extractor basket into an endoscope. The physician retrieved the pieces of crushed stones with the device after performing calculus fragmentation. After several attempts of stone retrieval, the physician noticed that the shaft of the device was kinked and separated. The physician used another device to complete the procedure. There was no patient harm reported and no additional procedures were required because of this failure.
 
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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 Key6665494
MDR Text Key202676657
Report Number1820334-2017-01433
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 distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
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 Received06/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/23/2017 Patient Sequence Number: 1
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