MAUDE Adverse Event Report: Wilson-Cook Medical Inc ACUJECT VARIABLE INJECTION NEEDLE; Endoscopic Injection Needle, Gastroenterology-urology

Model Number	G22525
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction

• Brand Name: ACUJECT VARIABLE INJECTION NEEDLE
• Common Device Name: Endoscopic Injection Needle, 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; NC
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105
• MDR Report Key: 50738496
• Report Number: 1037905-2026-00530
• Device Sequence Number: 10620354
• Product Code: FBK
• UDI-Device Identifier: 00827002225251
• UDI-Public: (01)00827002225251(17)290310(10)W5013999
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K190829
• 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): 09/11/2026

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: G22525
• Device Catalogue Number: VIN-23
• Device Lot Number: W5013999
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 160 LB