MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-625

Model Number	KD-625LR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the single use electrosurgical knife could not be extended in the inversion position.The issue occurred with six knives during the procedure.Three of the knives broke off directly outside of the patient's body.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
Reports are being submitted on three of the knives that broke off during the procedure.Please refer to the following event: patient identifier of (b)(6) is related to model number: kd-625lr, lot number: unknown.Patient identifier of (b)(6) is related to model number: kd-625lr, lot number: unknown.Patient identifier of (b)(6) is related to model number: kd-625lr, lot number: unknown.The customer reported the lot number for each knife was 23k or 26k; however, they were not able to trace the specific lot number for each device.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record for both reported lot numbers (23k and 26k) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation the specific cause of phenomenon could not be identified.However, multiple factors may have contributed to the knife wire breaking off: 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.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿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.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.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.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.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-625
• 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: 17630605
• Report Number: 9614641-2023-01240
• Device Sequence Number: 6473593
• Product Code: KNS
• UDI-Device Identifier: 04953170407826
• UDI-Public: 04953170407826
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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-625LR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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