MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-645

Model Number	KD-645L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
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 gastroenterology physician reported to olympus that the triangle plate of the single use electrosurgical knife came off during the diagnostic peroral endoscopic myotomy (poem) procedure.The knife tip was removed via aspiration.Reportedly the procedure was completed successfully with another device and procedure did not take longer than otherwise.No patient injury or complications were reported.Reportedly, the knife tip looked burned early in the procedure and settings on the generator were confirmed to be correct.
Event or Problem Description
The following additional event details were provided by the customer: the device tip fell into the submucosal tunnel after creating the tunnel and just before starting the peroral endoscopic myotomy (poem).The ablation device was programmed to ¿classic poem settings,¿ and no changes were made to the settings during the procedure.At the time of the tip breakage, the device was not pressing against tissue, nor experiencing mechanical stress.It was noted that while creating the tunnel, more ¿sparks¿ than usual were observed.The total duration of the tunnel creation was 31 minutes, and the duration of the myotomy was 34 minutes.It was confirmed that there were no patient complications due to this event.Furthermore, the physician reported that the event caused ¿a lot of stress,¿ because the poem had to be performed with a dualknife since only one triange tip (tt) knife was available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was not returned to olympus for evaluation.Therefore, the condition of the device could not be confirmed.However, it was confirmed (from the provided photo) that the tip of the device was burned off.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, the root cause could not be determined.However, the reported issue was likely caused by the following mechanism: 1.During tissue incision, an electrical discharge likely occurred due to one of the following factors: a.The setting of the electrosurgical unit was in coagulation mode when the device was used for the procedure.B.The 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 caused reduced strength.This might have caused the cutting knife to break and fall off.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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 and the triangle tip 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 and/or the triangle tip 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.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 and the triangle tip 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 < spray coagulation¿ ¿do not activate output continuously but activate it intermittently.Continuous activation may result in patient injury, such as bleeding, tissue damage, or thermal injury of non-target tissue.Breakage or deformation of the triangle tip and cutting knife may likely occur.¿ ¿stop activating output immediately if the triangle tip and the cutting knife are found to turn red while activating output.Keeping output activated while the triangle tip and the cutting knife are red may result in thermal injury.Detachment of the triangle tip and deformation/break of the triangle tip and cutting knife may also occur.¿ this supplemental report includes additional information received from the customer.B5 updated accordingly.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-645
• 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: 18031618
• Report Number: 9614641-2023-01636
• Device Sequence Number: 7017653
• Product Code: KNS
• UDI-Device Identifier: 04953170407857
• UDI-Public: 04953170407857
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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-645L
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUALKNIFE (MODEL AND SERIAL # UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown