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	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In preparation for a procedure, the user selected a cook acusnare polypectomy snare.It was reported [that the] user opened the package and found that the steel wire at the handle was exposed, so [user] replaced [device] with a new product to complete the procedure.This occurred prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
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 device pouch, and the lot number matches that in the report.The second photo shows the device handle, and the handle cannula was significantly kinked out of the side of the handle, confirming the complaint.Our laboratory evaluation of the product said to be involved confirmed the report.The snare returned fully retracted into the sheath.During a visual examination, it could be seen that the handle cannula was significantly kinked out of the side of the handle.When the handle was advanced, the handle cannula bent/kinked farther out of the side of the handle, and the snare head would not advance.When the handle was retracted, the handle cannula remained more kinked than the state it returned.The device history record for the lot number said to be involved was reviewed.A discrepancy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 and of the photos provided confirmed the report.A definitive cause for this observation could not be determined because the actual prior to use product preparation and handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The instructions for use direct the user to: "fully retract and extend snare to confirm smooth operation of device." damage to the product can occur if the device experiences excessive pressure during use.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.

• 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: 22955540
• Report Number: 1037905-2025-00636
• Device Sequence Number: 18550769
• Product Code: FDI
• UDI-Device Identifier: 10827002226293
• UDI-Public: (01)10827002226293(17)270702(30)10(10)W4850730
• 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,Followup
• Report Date (Section B): 09/30/2025

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: G22629
• Device Catalogue Number: AS-1-S
• Device Lot Number: W4850730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown