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

Model Number	KD-655U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.Three attempts were performed to obtain additional information, but no response was received from the customer.
Event or Problem Description
It was reported the single use electrosurgical knife broke off.The issue occurred during unspecified procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause could not be determined.The following are included in the instructions for use (ifu): -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.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 following conditions: -the condition of tissue to be cut or coagulated -the type/configuration/rated high-frequency voltage of the device that you use -the contact area (length) between the electrode and the tissue -operational conditions like use of injection solution, and so on -your therapeutic strategy (whether you put a priority on the prevention ofbleeding or on limiting thermal injury to surrounding tissue) ¿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.Three attempts were performed to obtain additional information, but no response was received from the customer.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: 19939173
• Report Number: 9614641-2024-01598
• Device Sequence Number: 7413909
• Product Code: KNS
• UDI-Device Identifier: 04953170377532
• UDI-Public: 04953170377532
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: Health Professional
• Device Model Number: KD-655U
• Was Device Available for Evaluation?: No
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown