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

Model Number	G22701
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
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.Difficulty with electrical current can lead to the sheath kinking/buckling.One possible cause of this report is use with an incompatible active cord.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)." the instructions for use contain the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." "inspect active cord.Cord must be free of kinks, bends, breaks and exposed wires to allow for accurate transfer of current.If an abnormality is noted, do not use active cord." "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: 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 colonoscopy, the physician used a cook acusnare polypectomy snare.It was reported [that] the snare failed - did not cut [polyp] with heat [subject of report].A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.While the complainant states that the patient was moved to theatres as the operators were unable to reopen the snare that was enclosed around the polyp, it is currently unknown what intervention was required due to this occurrence.
Additional Manufacturer Narrative
The investigation is ongoing.A follow-up emdr will be submitted within 30 days of receipt of new information.
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, 19 sealed devices from the lot number in the report were returned and evaluated.Sealed devices #1-19: 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 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: used device: 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.Difficulty with electrical current can lead to the sheath kinking/buckling.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.One possible cause of this report is use with an incompatible active cord.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)." the instructions for use contain the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." "inspect active cord.Cord must be free of kinks, bends, breaks and exposed wires to allow for accurate transfer of current.If an abnormality is noted, do not use active cord." "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: 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 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: 24405356
• Report Number: 1037905-2026-00088
• Device Sequence Number: 15917387
• Product Code: FDI
• UDI-Device Identifier: 00827002227019
• UDI-Public: (01)00827002227019(17)280916(10)W4971170
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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,Followup,Followup
• Report Date (Section B): 04/27/2026

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: G22701
• Device Catalogue Number: ASMH-1-S
• Device Lot Number: W4971170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 04/01/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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: ERBE ELECTROSURGICAL GENERATOR; OLYMPUS COLONOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown