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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION LITHOTRIPSY EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

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COOK ENDOSCOPY FUSION LITHOTRIPSY EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Catalog Number FS-LXB-3X6
Device Problem Split (2537)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2017
Event Type  malfunction  
Manufacturer Narrative
Concomitant products: acrobat calibrated tip wire guide (acro-35-260), fusion wire guide locking device (fs-wl-o-s). Investigation evaluation: our evaluation of the product said to be involved confirmed the report. The orange wire guide lumen on the distal end of the device has been stripped along its full length. The basket was returned partially retracted into the sheath. The basket extends and retracts as intended. The catheter has a kink 14 cm from the distal tip of the catheter. The device was returned with an unknown reddish liquid on the outside of the device, in the catheter lumen, and on the basket. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting. Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis. This limits our ability to conclusively determine a cause. The instructions for use state the following: "introduce device into endoscope accessory channel, relock wire guide into wire guide locking device. With elevator open, advance basket in short increments until endoscopically visualized exiting scope. " prior to distribution, all fusion lithotripsy extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
 
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion lithotripsy extraction basket. As reported to customer relations: "the basket was advanced over the guide wire and down the endoscope. When the basket began to exit the endoscope, the physician noticed the angle of the basket was incorrect. The basket was then removed and inspected. It was then discovered that the guide wire had ripped through the orange sheath. ".
 
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Brand NameFUSION LITHOTRIPSY EXTRACTION BASKET
Type of DeviceFFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key6817790
MDR Text Key83834667
Report Number1037905-2017-00556
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFS-LXB-3X6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/31/2017
Device Age2 MO
Event Location Hospital
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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