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

Model Number	KD-620LR
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	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tip of single use electrosurgical knife broke off during an upper esd-endoscopic submucosal dissection procedure (intraoperative inspection), and fell into the patient's stomach.It was retrieved using grasping forceps.The doctor replaced the device with another product of the same model number and completed the procedure.There was no impact on the patient and the current condition of the patient is reported as good.No additional sedation was required and no delay reported.No additional interventions were required.There were no adverse events or complications reported.No patient harm reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's (lm) investigation.The device was evaluated by olympus, and the incision knife was observed to be broken and melted near the tip cover.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the breakage of the cutting knife was likely caused by the following: 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 coagulation mode.The output activation time was too long.2) an 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 had reduced strength.This may have caused the cutting knife to bend.4) the knife broke, and it was no longer possible to push it out.However, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which states: ¿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 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.¿ ¿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 the cutting knife may break.When a high-voltage waveform must be used, minimize the duration of current application.Electrosurgical unit: voltage intensities of various waveforms soft coagulation < cut / pulse cut < forced coagulation¿ ¿do not activate output when the metal portion at the distal end of the endoscope is too close to or in contact with the cutting knife.This could burn the tissue and/or damage the endoscope.¿ ¿if the cutting knife is used in a high-humidity situation, it may be damaged by melting or elongation.¿ ¿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 a patient, operator, or assistant injury, such as thermal injury.It could also damage the endoscope, instrument, and/or a cord.8.2: rated high-frequency voltage cut: 1600 vp (3200 vp-p) coag: 2900 vp (5800vp-p)¿ ¿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.¿ this supplemental report includes an update to h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 20544625
• Report Number: 9614641-2024-02040
• Device Sequence Number: 7532380
• Product Code: KNS
• UDI-Device Identifier: 04953170453946
• UDI-Public: 04953170453946
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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-620LR
• Device Lot Number: 42K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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: Required Intervention
• Patient Sex: Male