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

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	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 establishment name: (b)(6) hospital.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported during a procedure, the probe fell into the patient's body and was recovered, the device was replaced and the procedure was completed.There was no patient injury.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus, and the following was observed: the hook of the cutting knife was broken and missing.The breakage area on the cutting knife was found to be melted upon visual observation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, a likely cause of the reported event is as follows: 1.Due to the factor described below, 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 coagulation mode.The output activation time was too long.2.Spark discharge occurred, and the part of the cutting knife became hot instantly.As a result, the strength of the cutting knife decreased.Also, the cutting knife became burnt.3.During tissue incision, a load was applied to the cutting knife which reduced the strength.This likely caused the cutting knife to break.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) 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.¿ "8.2 specifications.Rated high-frequency voltage.Cut: 1600 vp (3200 vp-p).Coag: 2900 vp (5800 vp-p).Compatible olympus electrosurgical unit.Esg-100".¿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 was 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 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 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¿.¿do not use this instrument with burnt tissue adhering to the cutting knife or tip.Use the instrument after removing the burnt tissue adhering with a lint-free cloth.¿ ¿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 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.¿ reference current output levels in combination with olympus electrosurgical unit esg-100.¿the high frequency waveforms provided in the table are standard current output levels, which are used in the most common cases to the best knowledge of olympus.When you operate the electrosurgical unit, always set an appropriate output level according to the conditions of tissue to be cut or coagulated, the type/configuration/ rated high frequency voltage of the devices you use, the contact area (length) between the electrode and the tissue, operational conditions like use of injection solution and so on, and your therapeutic strategy (whether you put a priority on the prevention of bleeding or on limiting thermal injury to surrounding tissue).It is the endoscopist¿s responsibility to set an appropriate waveform.¿ ¿the pulse cut mode provides intermittent cutting waves, while the cut mode provides continuous cutting waves.When you use the cut mode, be careful not to give an excessive cut to the tissue.¿ this supplemental report includes an update to h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 19746600
• Report Number: 9614641-2024-01437
• Device Sequence Number: 20479495
• Product Code: KNS
• UDI-Device Identifier: 04953170453946
• UDI-Public: 04953170453946
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: 3YK20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2023
• 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: 290T.; ESG.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown