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

Model Number	KD-620LR
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	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon evaluation of the returned device, it was found that the knife wire had melted and broken.The cutting knife was scorched.The hook shaped cutter head was fused.The lot no.Of subject device was 18k with supplementary information number of ¿05¿.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, the single use electrosurgical knife head broke off when it was used for the first time/turned on and fell into the patient's body and was subsequently removed.It was initially stated that the patient was not anesthetized but this was unable to be confirmed.The physician finished the case with another device of the same model.There were no patient injuries.
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 because of the following mechanism: 1) due to one of these factors, spark discharge between the tissue and the cutting knife occurred 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/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, deformation or break of the cutting knife 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.Moreover, if the cutting knife is withdrawn into the outer sheath immediately after the high-frequency output, the cutting knife may be deformed inside the outer sheath and become unable to be protruded from it.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 or the cutting knife cannot be protruded from the outer sheath, 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 outer sheath.Do not continue using an abnormal electrosurgical knife to prevent perforation or bleeding.If the 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 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 lead to melting or elongation of the hook extremity, making it impossible to extrude the cutting knife from the outer sheath.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 - be careful not to use excessive force when removing tissue attached to the cutting knife.When the distal end 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." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 17485002
• Report Number: 9614641-2023-01124
• Device Sequence Number: 12719341
• Product Code: KNS
• UDI-Device Identifier: 04953170208409
• UDI-Public: 04953170208409
• 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
• 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-620LR
• Device Lot Number: 18K05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• 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: 10/25/2022
• 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: 08/05/2021
• 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