MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-612

Model Number	KD-612U
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	09/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The territory manager reported on behalf of the customer that during a therapeutic, peroral endoscopic myotomy procedure, the tip of the single use electrosurgical knife broke and fell inside the patient body and broken tip was retrieved.There was no medical intervention required other than the retrieval of the fallen device.The procedure was completed with a similar device with a delay of around 30 minutes.Further follow-up with the customer has been conducted but additional information is unavailable at the time of this report.No patient injury or harm reported.The device was inspected prior to use of the procedure.
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 tip was detached 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 poem, high output settings, such as spray coagulation, were used for activation.2.) due to the mechanism described in the first point above, a spark discharge occurred between the tissue and the electrode during output activation.3.) high heat caused by spark discharge was locally applied to the tip and the electrode.This caused the adhesive strength of the adhesive agent which affixes the cutting knife and the tip to decrease.4.) a force to perform tissue incision was applied to the tip.Due to the description stated above 3, the adhesive strength of the adhesive agent decreased causing the tip detachment.However, the root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: "when the electrosurgical unit is used in the coagulation mode, crack/detachment of the tip and the electrode or deformation/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 cracks or detachment of the tip or deformation/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 insertion portion of this instrument.Do not continue using an abnormal electrosurgical knife to prevent perforation or hemorrhages.If the tip or cutting knife is detached be sure to collect it using grasping forceps." "aspirate fluids such as mucus that adhere to the electrode and/or the cutting knife, outer sheath and body cavity tissues.Patient injury such as punctures, hemorrhages, mucous membrane damage and thermal injury of tissue could result if output is activated when in contact with these adhering fluids.When current is discharged while the cutting knife is being separated from the mucosa under wet situation, it may break the cutting knife or crack the tip." "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 punctures, hemorrhages or mucous membrane damage.Application of high-voltage waveforms for extended periods increase the likelihood that it may break the cutting knife or crack the tip.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" additional information inadvertently left out: it was reported that the diathermy unit and the setting were the following: swift coagulation 2.4 and endo cut 1 2 on the latest vio 3 erbe.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-612
• 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: 17986350
• Report Number: 9614641-2023-01572
• Device Sequence Number: 8199508
• Product Code: KNS
• UDI-Device Identifier: 04953170325939
• UDI-Public: 04953170325939
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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-612U
• Device Lot Number: 2YK22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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: 290 CF GASTROSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown