MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACCUSNARE POLYPECTOMY SNARE; ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES

Model Number	G22633
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During an unspecified polypectomy the physician used a cook acusnare polypectomy snare.It was reported that the product would open and close fine.When trying to grab the polyp the product would bunch up instead of cutting through [snare will not cut through entire polyp - subject of report].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 did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.However, five sealed devices from the lot number provided in the report were returned and evaluated.Sealed devices #1-5: our laboratory evaluation of the sealed devices could not confirm the report as it was described, the devices functioned as intended.The devices were submitted to the engineering test lab (etl) and were functionally tested to verify that a polypectomy could be performed successfully.The etl determined in test log that the devices met the requirements.The snares attached to the active cord, advanced through the scope, advanced out of the device, ensnared and electrosurgically incised tissue, retracted back into the device, and removed from the scope all as expected.Therefore, the complaint could not be confirmed for the sealed devices.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: sealed devices: a definitive cause for the reported observation could not be determined because the products said to be involved functioned as intended.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The additional 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.Additional comments regarding this report: the additional information provided by the user stated that a cold polypectomy was performed.This is against the intended use of the device.A cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: ACCUSNARE POLYPECTOMY SNARE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES
• 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 ; 3367440157
• MDR Report Key: 23543036
• Report Number: 1037905-2025-00771
• Device Sequence Number: 9449423
• Product Code: FDI
• UDI-Device Identifier: 00827002226333
• UDI-Public: (01)00827002226333(17)280807(10)W4962031
• 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): 12/10/2025

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: G22633
• Device Catalogue Number: SASM-1-S
• Device Lot Number: W4962031
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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: ENDOSCOPE - UNKNOWN MAKE OR MODEL
• Patient Sex: Male