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

Model Number	G22632
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
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 device pouch and the label matches that in the report.The second photo shows the handle of the device and it can be seen that the handle cannula has a significant kink in it.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 kink created a kink in the sheath from the base of the handle to approximately 2cm from the base of the handle.During a functional test, the snare would advance with some difficulty but would retract with significant resistance encountered.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.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.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.
Event or Problem Description
During an enteroscopy inspection in colon, the physician used a cook acusnare polypectomy snare soft.It was reported [that] user opened the package and advanced the device into intestinal tract through endoscope working channel.When readying to open the snare, it was found that there was great resistance and the supporting sheath deformed.User retracted the device and endoscope, and changed to another device to complete the procedure.Further information determined that the snare was difficult to retract.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 (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
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 21950830
• Report Number: 1037905-2025-00355
• Device Sequence Number: 20966150
• Product Code: FDI
• UDI-Device Identifier: 00827002226326
• UDI-Public: (01)00827002226326(17)270829(10)W4866590
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: G22632
• Device Catalogue Number: SAS-1-S
• Device Lot Number: W4866590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS GASTROSCOPY
• Patient Age: 58 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG