MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE SOFT; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G22703
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: device 1: our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the snare fully retracted.When the handle was manipulated, the snare advanced and retracted as intended.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.A functional test was performed on simulated tissue with the acusnare.The active cord would connect easily and remained securely connected.The device was connected to a valley lab generator and power was applied.The snare cut the simulated tissue with some difficulty, the sheath near the distal end of the handle began to bunch up and cause resistance while cutting the tissue.Device 2: our laboratory evaluation of the product said to be involved did not confirm the report as described.The device returned with the snare fully retracted.When the handle was manipulated, the snare advanced and retracted as intended.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.A functional test was performed on simulated tissue with the acusnare.The active cord would connect easily and remained securely connected.The device was connected to a valley lab generator and power was applied.The snare cut the 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: 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 states: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." instructions for use states: "fully retract and extend snare to confirm smooth operation of device." instructions for use states: "inspect active cord.Cord must be free of kinks, bends, breaks, and exposed wires to allow for accurate transfer of current.If an abnormality is noted, do not use active cord." 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 two (2) separate polypectomy procedures, the physician used a cook acusnare polypectomy snare soft (one device in each procedure).As they're cutting through the polyps with the snares, the snare sheaths just distal to the handles would buckle to the point where they wouldn't be able to cut through the polyps (or finish the polypectomy.In order to complete the procedures, they had to open the snares back up to manually reinforce it with their fingers.All this happened while the devices remained in the scopes during the procedures.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: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 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: 12926924
• Report Number: 1037905-2021-00660
• Device Sequence Number: 4957885
• Product Code: KNS
• UDI-Device Identifier: 00827002227033
• UDI-Public: (01)00827002227033(17)240907(10)W4513311
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K851958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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 Expiration Date: 09/07/2024
• Device Model Number: G22703
• Device Catalogue Number: SASMH-1-S
• Device Lot Number: W4513311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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: OLYMPUS PCF 190 COLONOSCOPE
• Patient Sex: Unknown