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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCOMPASS NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NCOMPASS NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NC3-024115
Device Problems Kinked (1339); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/27/2017
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged. Investigation ¿ evaluation. (b)(4). A review of manufacturing instructions, specifications, quality control data, documentation, visual inspection, and functional testing was conducted during the investigation. A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident. The complaint device was returned for evaluation. The device was found to be non-functional due to a severe sheath kink at the support tube. The ifu contains a caution to not use excessive force to manipulate the device, or damage to the device may occur. It is unknown if excessive force was used on the device. 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 ncompass nitinol stone extractor wire kinked approximately 3cm from the basket handle, preventing operation of the basket. No unintended portion of the device remained inside the patient¿s body. No additional procedures were required due to this occurrence. No adverse effects or consequences were reported to the patient due to this occurrence.
 
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Brand NameNCOMPASS NITINOL STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7171670
MDR Text Key286445129
Report Number1820334-2018-00035
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 03/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNC3-024115
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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