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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

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COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Model Number G25149
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the drive wire had separated from the handle. The device was returned with a clear liquid inside the tubing. During a function test the handle was manipulated however no basket movement was noted. The device was disassembled and it was noted that the drive wire had separated from the handle and there was wire nesting inside the purple hub. For further evaluation of the drive wire cable and basket, the catheter was cut to push the drive wire cable out of the sheath. The basket is fully formed and intact. Solder is present on the handle cannula at the joint. No other anomalies were detected with the device. 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. Basket advancement/retraction difficulties and nesting of the drive wire can occur if the device experiences excessive pressure. Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle. The instructions for use indicate: "advance device through channel, in short increments, until basket sheath exits endoscope. " the instructions for use state: "confirm desired position of basket sheath relative to target. Advance basket out of sheath. Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable. " prior to distribution, all memory ii double lumen 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: 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 bile duct lithotripsy, the physician used a cook memory ii double lumen extraction basket. The basket was advanced to the target site and the user attempted to push the handle to open the basket, but the user felt resistance and the basket would not open. Another of the same device was used instead and the procedure was completed. There was no reportable information at this time. The device was evaluated on 07-jun-2019 and it was determined that the drive wire was broken. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameMEMORY II DOUBLE LUMEN EXTRACTION BASKET
Type of DeviceFFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
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 Key8752950
MDR Text Key152093965
Report Number1037905-2019-00361
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002251496
UDI-Public(01)00827002251496(17)200502(10)W3855656
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/02/2020
Device Model NumberG25149
Device Catalogue NumberMB-35-2X4-8
Device Lot NumberW3855656
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2017
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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