MAUDE Adverse Event Report: Wilson-Cook Medical Inc (Cook Endoscopy) ACUSNARE POLYPECTOMY SNARE; Endoscopic electrosurgical unit and accessories

Model Number	G22649
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Common Device Name: Endoscopic electrosurgical unit and accessories
• Manufacturer (Section D): Wilson-Cook Medical Inc (Cook Endoscopy); 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): Wilson-Cook Medical Inc (Cook Endoscopy); 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: 50738189
• Report Number: 1037905-2026-00529
• Device Sequence Number: 18796628
• Product Code: FDI
• UDI-Device Identifier: 00827002226494
• UDI-Public: (01)00827002226494(17)281112(10)W4986065
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 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: G22649
• Device Catalogue Number: ASDB-25-015-S
• Device Lot Number: W4986065
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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
• Patient Sex: Unknown