MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY II DOUBLE LUMEN EXTRACTION BASKET; BILIARY CATHETER AND ACCESSORIES

Model Number	G25149
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.A corrective action (capa) has been initiated to address instances of difficulty during basket advancement and retraction.The product said to be involved is included in the scope of the corrective actions.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: a corrective action (capa) has been initiated in an effort to reduce occurrences of this nature.The product said to be involved is included in the scope of the corrective action.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During stone extraction in the common bile duct, the physician selected two cook memory ii double lumen extraction baskets.It was reported that before using it on the patient, the operation was checked.The handle moved, but the basket did not move.The basket is packaged with the basket extended so this is interpreted as unable to retract the basket.This occurred prior to patient contact; there was no impact to the patient.In addition, the user sustained no clinical consequence and there were no adverse effects to the user.

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION BASKET
• Common Device Name: BILIARY CATHETER AND ACCESSORIES
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 24260775
• Report Number: 1037905-2026-00065
• Device Sequence Number: 9766785
• Product Code: LQR
• UDI-Device Identifier: 00827002215382
• UDI-Public: (01)00827002215382(17)280724(10)W4958019
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K171969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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
• Operator of Device: Health Professional
• Device Model Number: G25149
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4958019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JAG WIRE 0.025 INCH (STRAIGHT TYPE).; OLYMPUS, TJF-290V SCOPE.
• Patient Sex: Unknown