MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION WIRE GUIDE LOCKING DEVICE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G31522
Medical Device Problem Codes	Accessory Incompatible (1004); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Additionally, components from a second fs-wl-o-s device were included (a large purple seal and white foam piece), lot unspecified, which was reportedly disassembled by the user as part of their initial investigation into the source of the foam.The orange wire lock component and partial bottom seal segment were unable to be definitively assigned to the complaint piece or the additional returned device.Our laboratory evaluation of the product said to be involved confirmed the report.The complaint piece was split/torn open half way through the bottom seal exposing the interior of the seal.Evidence of adhesive was observed within the lock as portions of the foam piece remained adhered to the interior surfaces of the purple top seal.The majority of the foam was returned detached from the purple seal.Both the detached portion of the foam and remaining foam within the lock are stained a dark yellow.Under magnification the foam was confirmed to have been slit and the center of the foam has been fully cut.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.The device history record for the lot number 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 product said to be involved confirmed the reported detachment of the foam piece from within the wire lock.The additional information provided indicated that water soluble lubricant was not applied to the top of the seal cap prior to insertion of accessories.The instructions for use indicate: "apply water-soluble lubricant to top of cap as needed to ease passage of accessories." this is the most likely cause for the detachment of the foam during accessory usage.Prior to distribution, all fusion wire guide locking devices 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.This report represents an unusual occurrence.Based on this review, the likelihood of this type of report is remote.Quality assurance will continue to monitor for complaint trends.Additional comments: based on the information provided that a water-soluble lubricant was not applied to the top of the cap prior to advancement of the accessories, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion wire guide locking device.It was reported that the device fell apart during use.The sponge and seals all came apart from the plastic handle.The sponge fell down the scope and into the patient [subject of report].They had to fish the sponge out of the patient.The procedure was successfully completed with another device of the same type.The foam piece fell down the scope and into the patient.It was not specified how it was retrieved, but a section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FUSION WIRE GUIDE LOCKING DEVICE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 24912981
• Report Number: 1037905-2026-00181
• Device Sequence Number: 15902595
• Product Code: OCY
• UDI-Device Identifier: 00827002315228
• UDI-Public: (01)00827002315228(17)290107(10)W4997929
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: G31522
• Device Catalogue Number: FS-WL-O-S
• Device Lot Number: W4997929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2026
• 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: SCOPE, UNKNOWN MAKE OR MODEL.; SPHINCTEROTOME, UNKNOWN MAKE AND MODEL.; WIRE GUIDE, UNKNOWN MAKE AND MODEL.
• Patient Sex: Unknown