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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 Problems Fracture (1260); Solder Joint Fracture (2324)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: acrobat 2 calibrated tip wire guide (awg2-35-450). Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report and determined that the drive wire separated from the handle. The basket was returned retracted in the tubing with a clear liquid still inside the tubing. The basket did move slightly however the basket would not retract when the handle was manipulated. The device was disassembled and noted that the drive wire had separated and nesting was observed in 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 was fully formed and intact. Solder was present on the handle cannula at the joint. The nesting of the drive wire contained discolorations. 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 retrograde cholangiopancreatography (ercp), the physician used a cook memory ii double lumen extraction basket. The doctor asked the nurse to prepare the basket for stone removal. The nurse unpacked the product package, and pulled and pushed the handle to confirm the product [would actuate]. There was no problem at that time. However, after the basket was inserted in the common bile duct (cbd), when she tried to open the basket, the handle did not move. There was no reportable information at this time. The device was received on 07-aug-2019 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 Key8951783
MDR Text Key156300935
Report Number1037905-2019-00509
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeKR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/13/2021
Device Model NumberG25149
Device Catalogue NumberMB-35-2X4-8
Device Lot NumberW4115019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2018
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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