MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACUSNARE POLYPECTOMY SNARE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	ASJ-1-S
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear biohazard bag with a micro label from the lot number provided in the report.The micro label matches the product returned.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with the snare retracted into the sheath.During a visual examination, there was noted a yellowish substance throughout the length of the catheter.The device would advance and retract as intended when the handle was manipulated.The continuity from the electrical pins 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 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: our functional evaluation of the device did not confirm the report.When tested with simulated tissue the returned device operated 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.The instructions for use contain the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." 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 remote.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, the physician used a cook acusnare polypectomy snare.It was reported [that] the cautery would not work when hooked up to the cautery.It was a huge polyp.They were trying to remove it piece-meal, not all at once.The procedure was successfully completed with another device of the same type (unknown lot).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: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 8002454707
• MDR Report Key: 17943844
• Report Number: 1037905-2023-00507
• Device Sequence Number: 20700014
• Product Code: KNS
• UDI-Device Identifier: 00827002226302
• UDI-Public: (01)00827002226302(17)260303(10)W4706442
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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: 03/03/2026
• Device Catalogue Number: ASJ-1-S
• Device Lot Number: W4706442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/16/2023
• 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: OLYMPUS PCF-190 ENDOSCOPE.
• Patient Sex: Unknown