MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-612; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	KD-612L
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon evaluation of the returned device, it was found that the device had crystal attachment and the knife head was fused.The cutting knife was broken and scorched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.¿.
Event or Problem Description
A customer reported to olympus that during an endoscopic submucosal dissection procedure, the cutter head of the single use electrosurgical knife kd-612 broke while the attachment was powered on.The broken part fell into the patient and was subsequently removed.This created a 15 minute delay; the surgeon then finished the case with another device.No other patient injury was reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the knife broke and fell into the patient body because of the following mechanism: 1) due to one of these factors, spark discharged between the tissue and the cutting knife during output activation: the output setting for activation was too high; the electrosurgical unit was used in the coagulation mode; the output activation time to was too long; contact length between the tissue and the cutting knife was short.2) high heat caused by spark discharge was locally applied to the cutting knife.Therefore, the strength of the cutting knife decreased.The cutting wire was also scorched.3) a force to perform tissue incision was applied to the cutting wire which has the reduced strength.This caused the cutting knife to break and fall off.A definitive root cause cannot be identified.The event can be detected and prevented by following the instructions for use which state: - "do not use this instrument and a cord with an output higher than the rated high-frequency voltage given in the tables in section 8.2, ¿specifications¿.This could cause patient, operator or assistant injury, such as thermal injury.It could also damage the endoscope, instrument and/or a cord.- when the electrosurgical unit is used in the coagulation mode, crack/detachment of the tip or deformation/break of the cutting knife or the electrode 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 cracks or detachment of the tip or deformation/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 insertion portion of this instrument.Do not continue using an abnormal electrosurgical knife to prevent perforation or bleeding.If the tip or cutting knife is detached be sure to collect it using grasping forceps.- 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 occur in patient injury, such as perforations, bleeding or mucous membrane damage.Application of high-voltage waveforms for extended periods increase the likelihood that it may break the cutting knife or crack the 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 - do not activate output continuously but activate it intermittently.Continuous activation may cause patient injury, such as bleeding, mucous membrane damage, or thermal injury of non target tissue.Crack/detachment of the tip or deformation/break of the cutting knife or electrode may also occur.- be careful not to use excessive force when removing tissue attached to the cutting knife.When the tip is subjected to excessive force, for example, when scraping with excessive force the cutting knife by tweezers, etc.Or when extending and retracting the cutting knife abruptly and continuously, it may break the cutting knife or crack the tip.- do not activate output when the electrode and cutting knife are not in contact with the target tissue.Crack/detachment of the tip or deformation/break of the cutting knife or electrode may occur." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-612
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17485034
• Report Number: 9614641-2023-01125
• Device Sequence Number: 15421756
• Product Code: KNS
• UDI-Device Identifier: 04953170325892
• UDI-Public: 04953170325892
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

1 Device was Involved in the Event

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 Model Number: KD-612L
• Device Lot Number: 17K20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2022
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown