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

Catalog Number	AS-1-S
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a colonic polyp ablation, the physician used a cook acusnare polypectomy snare.It was reported [that] the noose [snare loop] could not be completely tightened.Electricity must be used more often.The minimal residual tissue stalk could not be severed with the snare.This was finally achieved with a lot of manipulation and subsequent bleeding.The doctor said the polyp was normal and not particularly large.A section of the device did not remain inside the patient¿s body.The patient required hemostasis.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.
Additional Manufacturer Narrative
Section g: pma/510(k):k173673.Investigation evaluation: the product said to be involved was returned in a clear plastic bag with an open pouch from the lot number provided in the report.The label matches the product returned.Additionally, two sealed devices from the lot number provided in the report were returned and evaluated.Used device: our laboratory evaluation of the product said to be involved could not confirm the report as described.The device returned with no damage to the sheath or the handle.The snare was returned fully retracted and during a function test the handle was manipulated and the snare advanced/retracted with minimal difficulty.The continuity from the electrical pins to the snare head was tested with an ohm meter and passed.During a functional test, the snare was advanced into the accessory channel of a pentax colonoscope (2.8mm channel) which was placed in a simulated lower gi position.The tip of the scope was retroflexed to simulate worst case scenario.With handle manipulation, the snare advanced/retracted with little to no difficulty.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 as expected.No anomalies were detected with the device.Sealed devices #1 - #2: our evaluation of the sealed devices returned could not confirm the report as it was described, the devices functioned as intended.The devices returned with no damage to the sheaths or the handles.The snares were returned fully retracted and during a function test the handles were manipulated and the snares advanced/retracted with no issues.The continuity from the electrical pins to the snare heads was tested with an ohm meter and they both passed.During a functional test, the snares were advanced into the accessory channel of a pentax colonoscope (2.8mm channel) which was placed in a simulated lower gi position.The tip of the scope was retroflexed to simulate worst case scenario.With handle manipulation, the snares advanced/retracted with no issues.An additional functional test with the devices was performed by attaching the active cord to the electrical pins.The active cord connected to the devices easily and remained securely connected.The devices were connected to a valley lab generator and power was applied.The snares cut and coagulated simulated tissue as expected.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: our laboratory evaluation of the device could not confirm the report as described, the snare advanced, retracted, cut and coagulated simulated tissue as expected.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.Sealed devices: our laboratory evaluation of the devices could not confirm the report.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.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: 18365667
• Report Number: 1037905-2023-00631
• Device Sequence Number: 18146173
• Product Code: FDI
• UDI-Device Identifier: 00827002226296
• UDI-Public: (01)00827002226296(17)260303(10)W4706449
• Combination Product (Y/N): N
• PMA/510(K) Number: K851958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 03/03/2026
• Device Catalogue Number: AS-1-S
• Device Lot Number: W4706449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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: ENDOSCOPE - OLYMPUS 190
• Patient Sex: Unknown