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

Model Number	G22630
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a polypectomy procedure, the physician used a cook acusnare polypectomy snare.The snare was attempted to be used as a cold snare "[off label use]".It was reported that when the polyp was to be removed by the snare, it was found that the snare could not be retracted to remove the polyp.Therefore, use removed the device and replaced it for treatment.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 experienced redness and swelling.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the photos provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photos describing the event.The first photo shows the pouch label, and the lot number matches that in the report.The second photo shows the distal end of the device, and the snare head is advanced; however, we cannot see the handle to see its corresponding position.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: the information provided by the user stated that a cold polypectomy was performed.This is against the intended use of the device.The instructions for use state: "this device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.Do not use this device for any purpose other than the stated intended use." this is the most likely cause of the report.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional testing 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: 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: 50267602
• Report Number: 1037905-2026-00418
• Device Sequence Number: 21418950
• Product Code: FDI
• UDI-Device Identifier: 00827002226302
• UDI-Public: (01)00827002226302(17)290317(10)W5016173
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2026

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: G22630
• Device Catalogue Number: ASJ-1-S
• Device Lot Number: W5016173
• 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: 07/20/2026
• Initial Report FDA Received Date: 08/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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: Unknown Endoscope Make and Model.
• Patient Sex: Unknown