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

Catalog Number	ASMH-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	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section g: pma/510(k): k173673.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 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." 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.
Event or Problem Description
During a colonoscopy procedure, the physician used a cook acusnare polypectomy snare.It was reported [that the] snare is very stiff, difficult to close, [and] unable to ¿feel [snare]¿ if you are around the polyp during a polypectomy for colonoscopy because there is so much resistance when closing it.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a red biohazard bag with an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare retracted into the sheath.The device would advance and retract with some resistance when the handle was manipulated.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.An additional functional test with the device was performed by attaching the active cord to the electrical pin.The active cord connected to the device easily and remained securely connected.The device was connected to a valley lab generator and power was applied.The snare cut and coagulated simulated tissue with some difficulty; there was resistance as the snare was closing on the simulated polyp, 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 returned device confirmed the report, the snare cut and coagulated the simulated polyp with resistance.Additional information indicates the user attempted to cold snare which is off label for this device.The intended use for this device states: "this device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract." using the device without coagulation would exacerbate the resistance felt by the user.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." additionally, 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." 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.Additional comments: based on the information provided that the user attempted to cold snare, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During a colonoscopy procedure, the physician used a cook acusnare polypectomy snare.It was reported [that the] snare is very stiff, difficult to close, [and] unable to ¿feel [snare]¿ if you are around the polyp during a polypectomy for colonoscopy because there is so much resistance when closing it.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
• 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: 19491388
• Report Number: 1037905-2024-00316
• Device Sequence Number: 7024776
• Product Code: FDI
• UDI-Device Identifier: 00827002227019
• UDI-Public: (01)00827002227019(17)261214(10)W4793032
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: ASMH-1-S
• Device Lot Number: W4793032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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: UNKNOWN ENDOSCOPE.
• Patient Sex: Unknown