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	Foreign Body In Patient (2687)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 submucosal dissection, the tip of the knife detached and stuck in the mucosa.
Event or Problem Description
It was reported that the procedure was a gastroscopy and the scope was used for the gastrointestinal tract (gi) tract.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (a3 and b5) and to provide a correction to field (d9), and an update to field (d4, h3, and h4).The device was evaluated by olympus, and the distal end of the device was confirmed to be broken.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 that the reported event occurred due to the following mechanisms.1.) during tissue incision, an electrical discharge might have occurred due to one of 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.) in electrical discharge occurred, and the part of the cutting wire became hot instantly.As a result, the strength of the cutting knife decreased.Also, the cutting wire was scorched.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 root cause of the reported event could not be determined.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." "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, esg-400"."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.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 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 break the cutting knife.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 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19274524
• Report Number: 9614641-2024-01052
• Device Sequence Number: 6336030
• Product Code: KNS
• UDI-Device Identifier: 04953170377518
• UDI-Public: 04953170377518
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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-655Q
• Device Lot Number: 2ZK26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/06/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male