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

Model Number	G22701
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure to remove an anal polyp, the physician used a cook acusnare polypectomy snare.It was reported [that] cautery appeared not to be working.Per the information available in the med sun report, there were no clinical consequences to the patient or user.
Additional Manufacturer Narrative
The investigation is ongoing.A follow-up emdr will be submitted within 30 days of submission of this report.
Additional Manufacturer Narrative
This correction is being submitted for an update made to section b5 to include the fda report key id for cross reference.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.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 recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper selection, 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." "this device must only be used with an active cord compatible with a 3mm 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)." "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 unity 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.
Event or Problem Description
During a procedure to remove an anal polyp, the physician used a cook acusnare polypectomy snare.It was reported [that] cautery appeared not to be working.Per the information available in the med sun report, there were no clinical consequences to the patient or user.Report key id: (b)(4).
Event or Problem Description
During a procedure to remove an anal polyp, the physician used a cook acusnare polypectomy snare.It was reported [that] cautery appeared not to be working.Per the information available in the med sun report, there were no clinical consequences to the patient or user.
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.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 recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper selection, 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." "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)." "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 unity 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.

• 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): CWS.COMPLAINTS@COOKMEDICAL.COM; 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: 22322006
• Report Number: 1037905-2025-00473
• Device Sequence Number: 18389486
• Product Code: FDI
• UDI-Device Identifier: 00827002227019
• UDI-Public: (01)00827002227019(17)260811(10)W4754805
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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 Expiration Date: 08/11/2026
• Device Model Number: G22701
• Device Catalogue Number: ASMH-1-S
• Device Lot Number: W4754805
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 07/23/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/18/2025; 07/23/2025
• Date Device Manufactured: 08/11/2023
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE 15119442
• Patient Sex: Unknown