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

Model Number	G22629
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare retracted into the sheath.There was evidence of cautery present on the tip of the snare head.The device would 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 cut and coagulated simulated tissue with significant resistance during handle retraction.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 laboratory evaluation of the returned device confirmed the report.There was significant resistance during handle movement.The cause of this resistance was not identified during the investigation.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 remote.Quality assurance will continue to monitor for complaint trends.Additional comments: based on the information provided that an incompatible active cord was used, 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 an unknown endoscopic procedure, the physician used a cook acusnare polypectomy snare.It was reported [that] on the first polyp that the snare was used on, there was not a problem.However, on the second polyp that it was used on, it ripped the colonic mucosa approximately a cm in length.Upon removing the snare, it was noted that the loop felt unusually rough and abrasive.The polyp was successfully removed.A section of the device did not remain inside the patient¿s body.The patient required the affected mucosal area of injury to be clipped with 2 large clips to close the defect due to this occurrence.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• 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 ; 3367440157
• MDR Report Key: 21930010
• Report Number: 1037905-2025-00350
• Device Sequence Number: 15632060
• Product Code: FDI
• UDI-Device Identifier: 00827002226296
• UDI-Public: (01)00827002226296(17)270802(10)W4859311
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: G22629
• Device Catalogue Number: AS-1-S
• Device Lot Number: W4859311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE ACTIVE CORD; ESU - ERBE VI0 200 ELECTRICAL GENERATOR; UNKNOWN ENDOSCOPE MAKE AND MODEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown