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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC CAPTURA HELICAL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC CAPTURA HELICAL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number G32727
Device Problem Off-Label Use (1494)
Patient Problem Internal Organ Perforation (1987)
Event Type  Injury  
Manufacturer Narrative
(b)(6). Pma/510(k) # - exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
The surgeon reported an adverse event that occurred in one of his lists in (b)(6) 2018. The hospital ordered a urology basket (product ce-432115) and the surgeon, an upper gi consultant, used it to remove stones in the common bile duct (cbd) causing 2 perforations to the patient¿s ducts. The surgeon closed the perforations successfully and no further patient complication arose as a consequence to these perforations. The surgeon commented that the basket was rigid and the sheath had some resistance due to its coating when it was passed down the olsen-reddick clamp (which is used commonly in laparoscopic cbd cases). The surgeon was informed they had used an urology product in error that was not intended or licensed for use in the cbd. The surgeon doesn¿t feel it¿s cook¿s fault or a fault of this product (it was used off license without them really realizing it was the case). Additional information was provided. This product was ordered for cbd stones because it is the recommended replacement for obsolete product (cef-545065), captura helical stone extractor, used for stone manipulation and removal in the urinary tract. The hospital has been using this basket regularly to remove stones in the cbd for over a decade.
 
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Brand NameCAPTURA HELICAL STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8271042
MDR Text Key133867387
Report Number1820334-2019-00203
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/06/2021
Device Model NumberG32727
Device Catalogue NumberCE-432115
Device Lot Number9143787
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2018
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: 01/23/2019 Patient Sequence Number: 1
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