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

Model Number	G22702
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white plastic bag with an open pouch from the lot number provided in the report.The label matches the product returned.Photos were provided and reviewed.The first photo shows the snare head advanced, and the snare head has frayed.The second photo shows the pouch, and it matches the lot number in the report.Our laboratory evaluation of the product said to be involved confirmed the report, the snare head had pieces of the tip frayed.The device was returned with the snare retracted into the sheath.A reddish-brown liquid was present throughout the distal end of the catheter and on the snare head.The snare head was able to advance and retract as expected when the handle was manipulated.The snare head was confirmed to be the correct component.The continuity from the electrical pins to the snare head was tested with an ohm meter and passed.An additional functional test with the device was performed by attaching the active cord to the electrical pin.The active cord connected to the device easily and remained securely connected.The device was connected to a valley lab generator and power was applied.The snare only minimally cut and coagulated simulated tissue; it took significant time and repetitions to remove simulated tissue.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: our evaluation of the returned device and photos provided confirmed the report; the snare head was frayed.The snare head being frayed can interfere with cutting ability.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Additional information provided states this device was used with an olympus 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 remote.Quality assurance will continue to monitor for complaint trends.Additional comments: based on the information provided that the device was used with an incompatible active cord, 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.
Event or Problem Description
During a thermal polypectomy on the duodenum, the physician used a cook acusnare polypectomy snare soft.It was reported [that] when the device was energized, the snare instantly melted and burred when the power was on.The user replaced the device with another of the same rpn to complete the procedure.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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE SOFT
• 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
• MDR Report Key: 22904938
• Report Number: 1037905-2025-00619
• Device Sequence Number: 18375764
• Product Code: FDI
• UDI-Device Identifier: 10827002227023
• UDI-Public: (01)10827002227023(17)280203(30)10(10)W4910795
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K173673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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: G22702
• Device Catalogue Number: SASH-1-S
• Device Lot Number: W4910795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ACTIVE CORD; OLYMPUS ESG-400; OLYMPUS GIF - H 260
• Patient Age: 68 YR
• Patient Sex: Male