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

Catalog Number ASMH-1-S

Device Problems Off-Label Use (1494); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

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.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the additional information provided by the user stated that a cold polypectomy was performed.This is against the intended use of the device.The intended use for this device states: "this device is used with an electrosurgical unit for endoscopy polypectomy.Do not use this device for any purpose other than the stated intended use." this is the most likely cause of the report.The instructions for use contains 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." "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." "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." "fully retract and extend snare to confirm smooth operation of device." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode." prior to distribution, all acusnare polypectomy snares soft are subjected to a visual inspection and functional testing to ensure device integrity.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 regarding this report: based on the information provided that the product was used off label for cold snaring, 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 Description

During an endoscopic procedure, the physician used a cook acusnare polypectomy snare.The nurse stated that the snare did not cut through the polyp during a routine polypectomy.The sheath buckled and nothing happened.They changed to another snare and the procedure was completed.In a discussion [with the nurse], the nurse believes that diathermy [electro-cautery] was not being used.They were attempting to "cold snare" the polyp [off label].

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could confirm the report as it was described.The device was returned and the sheath was kinked from the base of the handle to approximately 2 cm.There was a second kink in the sheath at 87 cm from the base of the handle.The user not using a generator could have contributed to the kinks in the sheath.A functional test was performed on the device.The device was advanced through an ec-3830 tl pentax colonoscope (2.8 mm channel).The scope was placed in a curved position to demonstrate a worst case scenario.Once the device was successfully through the distal end of the colonoscope, the handle was actuated to test for advancing and retracting of the snare head.The snare would open and close as intended.Resistance was not encountered when opening and closing the snare.The active cord would connect easily and remained securely connected.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected to a valley lab generator and power was supplied.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: the additional information provided by the user stated that a cold polypectomy was performed.This is against the intended use of the device.The intended use for this device states: "this device is used with an electrosurgical unit for endoscopy polypectomy.Do not use this device for any purpose other than the stated intended use." this is the most likely cause of the report.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." "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." "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." "fully retract and extend snare to confirm smooth operation of device." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode." prior to distribution, all acusnare polypectomy snares soft are subjected to a visual inspection and functional testing to ensure device integrity.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 regarding this report: based on the information provided that the product was used off label for cold snaring, 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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7374906
• MDR Text Key: 103926997
• Report Number: 1037905-2018-00114
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASMH-1-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - UNKNOWN MAKE OR MODEL