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U.S. Department of Health and Human Services

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

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COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NGE-022115
Device Problem Difficult to Open or Close (2921)
Patient Problem No Patient Involvement (2645)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation: a review of functional testing, drawings, manufacturing instructions, specifications, quality control data, and visual inspection of the actual device was conducted during the investigation. One device was returned for investigation. The device was returned with the handle between the open and closed position. The basket formation is in the open position. A visual examination noted the basket sheath has a kink from the distal tip and appears to have scrapes marks as well. There are also multiple kinks from the distal tip of the basket sheath and again at the distal tip of the support sheath. A functional test determined the handle will actuate the basket formation to the open position, but it is slow to close. It does eventually close completely. After several actuations, the basket open and closed fine. The device appeared to have debris at the tip, but once the debris was pushed out, the device functioned fine. It was determined that there are no other complaints for this lot number. A definitive cause cannot be established at this time. There is no evidence to suggest the product was not made to specifications. Measures have been previously initiated to address this issue and per the quality engineering risk assessment no further action is required. We will notify the appropriate personnel and continue to monitor for similar complaints.
 
Manufacturer Narrative
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 ngage nitinol stone extractor basket could not close completely. No patient involvement. No adverse effects or consequences were reported to the patient due to this occurrence.
 
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Brand NameNGAGE NITINOL STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7147711
MDR Text Key285528763
Report Number1820334-2017-04610
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,other,use
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 Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-022115
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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