MAUDE Adverse Event Report: Wilson-Cook Medical Inc FUSION WIRE GUIDE LOCKING DEVICE; Endoscopic Guidewire, gastroenterology-urology

Model Number	G31522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion wire guide locking device.It was initially reported that there was a product failure.There was no reportable information at this time.On 21 jul 2026 additional information was received stating that when securing the wire guide, one of the arms of the device broke.Then they use another wire guide locking device."[unable to lock wire guide]".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.
Additional Manufacturer Narrative
Continued e1 phone number: (b)(6).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 photos provided are associated with the first report (cook reference (b)(4)) and second report (cook reference (b)(4)), as they are labeled "device 1" and "device 2," and are therefore not associated with this record.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.Prior to distribution, all fusion wire guide locking devices 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• 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 ; +1(336)744-0157
• MDR Report Key: 50280010
• Report Number: 1037905-2026-00427
• Device Sequence Number: 13204371
• Product Code: OCY
• UDI-Device Identifier: 00827002315228
• UDI-Public: (01)00827002315228(17)290306(10)W5013167
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/17/2026

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: W5013167
• 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: 07/21/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2026
• 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: Olympus Scope, Unknown Model
• Patient Sex: Unknown