MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

Model Number	KD-640L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was reported by the user to the fda in the mw5094249.Due diligence for additional information was executed.There is no additional event or patient information available.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.
Event or Problem Description
As reported for this event, during procedure the device triangle tip knife broke off in the patient.The broken tip piece was retrieved from patient with standard forceps.There was no adverse impact to the patient.
Additional Manufacturer Narrative
The device is not return but an evaluation has been completed based on historical data.This supplemental report is being submitted to provide this information.Please see the updates in sections: d10, g4, g7, h2, h3, h6, and h10.The device history review indicated no anomaly in manufacturing for the following: movement.Inclination of the triangle tip.Inclination of the cutting knife.Storage of the triangle tip.The subject device is not returned for investigation.Therefore, the root cause of the reported event cannot not be conclusively determined.Based on the similar investigation results, a likely cause of the event can be the following: electrical discharge possibly occurred between the tissue and the electrode due to the following factors: output level was too high.Device was used in the coagulation mode.Activation time was too long.Contact length between the tissue and the electrode was short.High heat was partially applied to the tip and the electrode due to an electrical discharge.This decreased the fixing strength of the welded part of the tip.A force was applied to the tip during tissue incision or cleaning of the cutting knife; the fixing strength of the welded part of the tip decreased.As a result, triangle tip disconnected and detached.The following details are found in the instruction for use (ifu) manual: when the electrosurgical unit is used in the coagulation mode, deformation or break of the cutting knife and the triangle tip could occur, for example when the high frequency output is set too high or the length of the contact between the cutting knife and tissue is too short.During treatment, always ensure that the slider slides on the handle smoothly and that the electrosurgical knife observed in the endoscopic image is normal.Should deformation or break of the cutting knife be detected during use, immediately shut off the power supply, discontinue the procedure, pull the slider and withdraw the endoscope from the patient with the cutting knife retreated in the coated outer sheath.Do not continue using an abnormal electrosurgical knife to prevent perforation or bleeding.If the triangle tip and/or cutting knife is detached, be sure to collect it using grasping forceps.Do not set the output value of the electrosurgical unit too high or too low.Also, do not allow the activation time to be too long or too short.Set the high-frequency output mode of the electrosurgical unit optimally according to the conditions of the tissue to be cut.An excessive or insufficient output value may result in perforation, bleeding, mucous membrane damage or thermal injuries to the non-target tissue.Always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as perforation, bleeding or mucous membrane damage.Application of high-voltage waveforms for extended periods increase the likelihood that it may break the cutting knife or triangle tip.When a high-voltage waveform has to be used, minimize the duration of current application.Electrosurgical unit: voltage intensities of various waveforms soft coagulation cut / pulse cut forced coagulation.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10144871
• Report Number: 8010047-2020-03287
• Device Sequence Number: 2924868
• Product Code: KNS
• UDI-Device Identifier: 04953170208423
• UDI-Public: 04953170208423
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: No Information
• Device Expiration Date: 02/28/2021
• Device Model Number: KD-640L
• Device Lot Number: 83K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1