MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACUSNARE POLYPECTOMY SNARE; FDI, SNARE, FLEXIBLE

Catalog Number	ASM-1-S
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic procedure in sigmoid colon, the physician used four cook acusnare polypectomy snare[s].It was reported that when inserting it [snares] into the cavity and trying to collect the fragment, there is resistance (sometimes to application and later to retraction) and locking at the moment of twisting, and she is unable to collect the fragment.Customer provided video showing resistance when advancing and retracting the snare.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.
Additional Manufacturer Narrative
Pma/510(k): section g: k173673.Investigation evaluation: a product evaluation was performed only by the video provided with this report because the products said to be involved were not provided to cook for evaluation.A photo of the lot number was not provided.The video provided shows one device coiled in 3 loops on a table top, the snare head is being advanced and retracted, and it appears there is some resistance in both advancement and retraction of the snare head, confirming the customer's complaint.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 evaluation of the video confirmed the report of resistance, however, 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 contains the following information to assist with proper setup and use of the device: "fully retract and extend the snare to confirm smooth operation of the device." additionally, the instructions for use states "following the electrosurgical unit manufacturer's instructions for settings, verify the desired settings and activate the electrosurgical unit.Securely connect the active cord to the device handle and electrosurgical use.Proceed with the polypectomy, upon completion of the polypectomy, turn the electrosurgical unit off." 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Common Device Name: FDI, SNARE, FLEXIBLE
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): 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: 20213842
• Report Number: 1037905-2024-00540
• Device Sequence Number: 17942659
• Product Code: FDI
• UDI-Device Identifier: 00827002226319
• UDI-Public: (01)00827002226319(17)261204(10)W4789729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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 Catalogue Number: ASM-1-S
• Device Lot Number: W4789729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FIJIFIL- EP 6000 ENDOSCOPE
• Patient Age: 64 YR
• Patient Sex: Female