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

Model Number	G22649
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Type of Reportable Event	Serious Injury
Event or Problem Description
During an endoscopic polypectomy procedure for a semi sessile colon polyp in the ascending colon, the physician used a cook acusnare polypectomy snare.They reported that polyp was approximately 1 cm in size.The device was connected to an erbe device the device did have electricity initially when coagulating/burning by lost electricity midway through burning before cut was initiated.There was some tissue damage from the snare getting stuck around the polyp without any watts going through.They were able to free the tissue and change out the snare for a different type and had no further issues.A section of the device did not remain inside the patient¿s body.The area was cauterized with another device and an instinct plus endoscopic clipping device was placed 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.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Additional information provided states this device was used with an erbe active cord, which is incompatible.The ifu states "this device must only be used with an active cord compatible with a 3 mm diameter connector.This device has only been verified to be compatible with the following cook active cords: acu-1 and acu-1-vl (supplied non-sterile)." "do not use this device with an active cord which has a maximum voltage rating less than 5kvp-p (2500 vp).This could cause thermal injury to the patient, operator, or assistant." the instructions for use contain the following additional information to assist with proper set-up and use of the device: "before using this device, follow the recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper placement and utilization of the patient return electrode.Ensure that a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure." "inspect the active cord.The cord must be free of kinks, bends, breaks and exposed wires to allow for the accurate transfer of current.If an abnormality is noted, do not use the active cord." "securely connect the active cord to the device handle and electrosurgical unit.The active cord fittings should fit snugly into both the device handle and electrosurgical unit.Following the instructions from the electrosurgical unit manufacturer, position the patient return electrode and connect it to the electrosurgical unit." "following electrosurgical unit manufacturer's instructions for settings, verify the desired settings and activate the electrosurgical unit.Note: the maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode." 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: additional information provided states this device was used with an erbe active cord, which is incompatible.The ifu states "this device must only be used with an active cord compatible with a 3 mm diameter connector.This device has only been verified to be compatible with the following cook active cords: acu-1 and acu-1-vl (supplied non-sterile).".

• Brand Name: ACUSNARE 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: 23442059
• Report Number: 1037905-2025-00741
• Device Sequence Number: 4695418
• Product Code: FDI
• UDI-Device Identifier: 00827002226494
• UDI-Public: (01)00827002226494(17)270723(10)W4855963
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K191048
• 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
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: W4855963
• 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: 10/08/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown