MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-645

Model Number	KD-645L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the single use electrosurgical knife had a small flame shoot out of the blade, the triangular ceramic tip disintegrated, and the handpiece leaked.The knife also could no longer extend.The issue occurred during a therapeutic endoscopic retrograde cholangiopancreatography procedure.The procedure was delayed about 15 minutes and the patient was sedated with propofol.The procedure was completed using a similar device.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation and investigation.Based on the results of the device evaluation, the event (triangular ceramic tip disintegration) was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the event (triangular ceramic tip disintegration) could not be identified.However, it¿s likely the cause is related to the following: 1) during the procedure, the amount of discharge increased due to the following factors: the high-frequency output was set too high.The electrosurgical unit was used in the coagulation mode.The output activation time was too long.2)an electrical discharge occurred, and the triangle tip became hot instantly.As a result, the triangle tip melted.The event is detectable/preventable by handling the device in accordance with the following instructions for use (ifu): use this instrument only in combination with products recommended by olympus.If combined with products not recommended by olympus, patient injury caused by increase in patient leakage current, operator injury, malfunction or equipment damage may result.Do not use this instrument in an output higher than the rated high-frequency voltage in the table on page 4.This could cause patient, operator, or assistant injury, such as thermal injury.It could also damage the endoscope, instrument.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 and the triangle tip 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 tube.Do not continue using an abnormal electrosurgical knife to prevent perforation or bleeding.If the cutting knife and/or the triangle tip is detached, be sure to collect it using a grasping forceps.Always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.An 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 increases the likelihood that the cutting knife and the triangle tip may break.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 < spray coagulation do not activate output continuously but activate it intermittently.Continuous activation may result in patient injury, such as bleeding, tissue damage, or thermal injury of non-target tissue.Breakage or deformation of the triangle tip and cutting knife may likely occur.Stop activating output immediately if the triangle tip and the cutting knife are found to turn red while activating output.Keeping output activated while the triangle tip and the cutting knife are red may result in thermal injury.Detachment of the triangle tip and deformation/break of the triangle tip and cutting knife may also occur.Be careful not to use excessive force when removing tissue attached to the cutting knife and the triangle tip.When the distal end is subjected to excessive force, for example, when forcibly scraping the cutting knife with tweezers, etc.Or when extending and retracting the cutting knife abruptly, and continuously, it may break the cutting knife and the triangle tip.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The event occurred during an endoscopic submucosal dissection procedure.
Additional Manufacturer Narrative
Corrected data: h3 (inadvertently omitted on the previous follow-up medwatch report).

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-645
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 19264636
• Report Number: 9614641-2024-01045
• Device Sequence Number: 12385385
• Product Code: KNS
• UDI-Device Identifier: 04953170407857
• UDI-Public: 04953170407857
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2024

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: Other
• Device Model Number: KD-645L
• Device Lot Number: 3ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 12/30/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 12/30/2024; 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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: VIO 3 ERBE HF DEVICE
• Patient Sex: Unknown