MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number	KD-655Q
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 establishment name: (b)(6) medical center.The device was returned and evaluated, and the customers allegations were confirmed; the incision knife was broken upon receipt and the fractured surface was charred and melted.The broken piece was not returned.A review of the device history record (dhr) found no abnormalities related to the reported phenomenon.It has been over 9 months since the subject device was manufactured.Based on the results of the investigation, it is likely the reported event occurred due to the damage of the cutting knife.A likely cause of the damage to the cutting knife might be the following: 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 the 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 has the reduced strength.This might have caused the cutting knife to break.However, the exact cause of spark discharge generation could not be identified.Therefore, the root cause of the reported event could not be determined.The instructions manual contains the following information.- 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 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.- do not activate output if floating from the tissue to be incised without aspirating mucus or other liquid, or if the contact length between the tissue and the cutting knife is too short, spark discharge is likely to occur, which may break the cutting knife.- do not activate output if the debris or tissue is attached to the cutting knife.If the debris or tissue is still attached to the cutting knife, withdraw this electrosurgical knife from the endoscope for wiping the debris or tissue away with lint-free cloths.- 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.- 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, ormucous 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.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The olympus representative reported on behalf of the customer that the tip of the single use electrosurgical knife broke at the first energization of the endoscopic submucosal dissection (esd) and fell into the body and was recovered.It is unknown where in the body the tip fell off or how it was recovered.There was no further medical or surgical intervention needed and no procedural delay.There was no health hazard or effect on the patient.The procedure was completed by replacing the device with a similar one.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17797826
• Report Number: 9614641-2023-01373
• Device Sequence Number: 5686224
• Product Code: KNS
• UDI-Device Identifier: 04953170405631
• UDI-Public: 04953170405631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2023

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-655Q
• Device Lot Number: 2ZK20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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: ESG-300, GIF-H290T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown