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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 07/29/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report and determined that the drive wire disconnected. The device was returned with a clear liquid still inside the tubing. The handle was manipulated and the basket did not move. The device was taken apart and noted that the drive wire had disconnected and there was nesting inside the 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 was fully formed and intact. Solder was 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 a stone removal procedure, the physician used a cook memory ii double lumen extraction basket. A duodenoscope was advanced into the patient, then the procedure of bile duct stone removal through the papilla was performed with a stone extraction balloon. After that, the basket was selected to clean the bile duct. After confirming that the basket opened and closed properly prior to use, the user inserted it through the duodenoscope and attempted to open the basket, but the basket did not open. Another manufacturer's basket device was used to complete the procedure. There have been no adverse effects to the patient reported. There was no reportable information at this time. On (b)(6) 2019 the device was received and the evaluation determined that the drive wire had disconnected from the handle. 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 Key8962136
MDR Text Key156609023
Report Number1037905-2019-00516
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002251496
UDI-Public(01)00827002251496(17)220417(10)W4204651
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 07/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/17/2022
Device Model NumberG25149
Device Catalogue NumberMB-35-2X4-8
Device Lot NumberW4204651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2019
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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