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

Model Number	G22631
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction

• Brand Name: ACUSNARE POLYPECTOMY SNARE SOFT
• 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: 50260221
• Report Number: 1037905-2026-00415
• Device Sequence Number: 10701334
• Product Code: FDI
• UDI-Device Identifier: 00827002226319
• UDI-Public: (01)00827002226319(17)290226(10)W5011117
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173673
• 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,Followup
• Report Date (Section B): 09/16/2026

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: G22631
• Device Catalogue Number: ASM-1-S
• Device Lot Number: W5011117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown