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 Patient Involvement (2645)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined drive wire separated from handle.The basket was returned extended from the sheath 14.9 cm.The handle was manipulated with no movement from the basket noted.The handle was disassembled and it was noted the drive wire had separated inside the handle.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 drive wire was completely separated from the handle cannula at the proximal end.Discoloration was present on the proximal end of the drive wire.The solder at the distal end of the handle cannula was broken and sliding freely.The basket was fully formed and intact.No other anomalies were detected with the device.A lab meeting was held with production management and supervision on 12/30/2019 to evaluate the solder, the review was unable to conclude a manufacturing defect associated with the solder process at the distal end of the handle cannula.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 prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all memory ii double lumen extraction baskets are subjected to a visual inspection 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

Prior to an endoscopic procedure, the attempted to use a cook memory ii double lumen extraction basket.Prior to insertion, the basket was checked and despite pulling the handle, the basket did not enter the sheath.There was no reportable information at this time.The device was evaluated on 13-dec-2019 and found to have the drive wire separated from the handle.This occurred prior to patient contact; there was no impact to the patient.

• 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: 9560539
• MDR Text Key: 195633611
• Report Number: 1037905-2020-00015
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002251493
• UDI-Public: (01)10827002251493(17)220822(10)W4253146
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2022
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4253146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2019
• 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