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

Model Number G25149

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: olympus visiglide wire guide, 0.025inch.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report and determined that the drive wire had separated from the handle assembly.The basket was returned with brown substance near the tip and with the basket sticking out approximately 13.2 cm.The basket was fully formed and intact.The white handle had yellow discoloring.During a function test the handle would move however the basket did not advance or retract with it.The handle collet was unscrewed and it was noted that the drive wire was not attached to the collet, indicating separation from the handle.For further evaluation of the drive wire cable, the handle was separated for removal of the drive wire.The wire was discolored near the basket.The drive wire was intact and measured to be 225.8 cm long with bends approximately 14.0 cm to 26.5 cm from the proximal end.A product-specific discrepancy or anomaly that could have caused or contributed to this observation was not observed during our laboratory analysis.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.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 extraction procedure, the physician used a cook memory ii double lumen extraction basket.While the user was advancing and retracting the handle, the basket became unable to respond to handle manipulation due to breakage of the basket wire(s).Another cook extraction basket was used to complete the procedure.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: 9273661
• MDR Text Key: 219963474
• Report Number: 1037905-2019-00668
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002251496
• UDI-Public: (01)00827002251496(17)220806(10)W4246250
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Model Number: G25149
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4246250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2019
• 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