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

Catalog Number MB-35-2X4-8

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the drive wire disconnected from the handle.The device was returned with the basket fully retracted into the sheath.During a function test the handle was manipulated, and no movement was noted from the basket.The device was disassembled, and it was noted that the drive wire had disconnected from the handle.There was nesting of the wire 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 was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.A dried yellow substance was observed on the device handle and injection port.No other anomalies were detected with the devices.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 also indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." the instructions for use states: "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." basket deployment difficulties and buckling/breaking 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.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 procedure, the physician used a cook memory ii double lumen extraction basket.The basket did not come out the sheath [prior to insertion the nurse checked the basket and there was no issue noted].This event was not reportable at the time.Device was received on 17-mar-2020 and during a function test the basket would not move when handle was manipulated.The handle was disassembled, and it was noted that the drive wire was disconnected from the handle with nesting inside the purple hub.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.

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION BASKET
• Type of Device: FFL, 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 Key: 9948881
• MDR Text Key: 227616217
• Report Number: 1037905-2020-00175
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002251493
• UDI-Public: (01)10827002251493(17)220926(10)W4266010
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K851965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4266010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1