MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION LITHOTRIPSY EXTRACTION BASKET; DISLODGER, STONE, BASKET, URETHRAL, METAL

Model Number	G48278
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open box from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully retracted and there was damage to the zip port.The orange section of the sheath (wire guide lumen) has split lengthwise at the distal end.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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: our evaluation of the returned device confirmed the wire guide lumen has split at the distal end.A definitive cause for this observation could not be determined.The ifu cautions: "damage to wire guide lumen may result if zip port is visible and device is pulled from accessory channel with wire guide locked in wire guide locking device.If wire guide lumen is damaged, discard device." prior to distribution, all fusion lithotripsy 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During endoscopic retrograde cholangiopancreatography (ercp) lithotripsy, the physician used a cook fusion lithotripsy extraction basket.It was reported that during advancement through the scope the wire guide lumen was detected to be damaged.The user changed to a new device 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: FUSION LITHOTRIPSY EXTRACTION BASKET
• Common Device Name: DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC ; 3367440157
• MDR Report Key: 24028286
• Report Number: 1037905-2026-00021
• Device Sequence Number: 18513355
• Product Code: FFL
• UDI-Device Identifier: 00827002482784
• UDI-Public: (01)00827002482784(17)280107(10)W4903050
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: G48278
• Device Catalogue Number: FS-LXB-3X6
• Device Lot Number: W4903050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS JF-260V SCOPE
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 62 KG