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	07/14/2026
Type of Reportable Event	Malfunction

• 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: 50279912
• Report Number: 1037905-2026-00426
• Device Sequence Number: 21303006
• Product Code: OCY
• UDI-Device Identifier: 00827002315228
• UDI-Public: (01)00827002315228(17)290306(10)W5013167
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/19/2026

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?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown