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	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During device evaluation at olympus, it was found the knife was broken.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over xxxx years since the subject device was manufactured.Although a definitive root cause of the electrosurgical knife could not be determined, based on the results of the investigation of the present product, we assume that the breakage of the incision knife was caused by the following mechanisms.1.During tissue incision, discharge occurred due to the following factors.2.The following factors caused the discharge during tissue incision: - the high-frequency ablation power supply was used in the coagulation mode.-the output setting was too high.-the power setting was too high.-the contact length between the tissue and the incision knife was too short.-the incision knife was locally subjected to high heat by the discharge, resulting in a decrease in strength (thinning).3.The knife was charred black and the fracture surface was melted and deformed.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following ifu : "-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.-be careful not to use excessive force when removing tissue attached to the cutting knife.When the tip 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 or crack the tip.-do not insert the instrument into the endoscope, if the cutting knife is not completely retracted into the outer sheath.The distal end of the insertion portion may extend from the distal end of the endoscope abruptly.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope and/or instrument if resistance is encountered during insertion, do not force the instrument.Reduce the angulation until the instrument passes smoothly.Forcing the instrument could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.Do not insert the instrument by force while the endoscope is angulated tightly.Otherwise, it may damage the endoscope and/or crack the tip." if additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported when using a dual knife during an endoscopic submucosal dissection (esd) procedure of the body of the stomach, the tip was damaged and dropped into the body.All the fragments that had fallen off were collected.While switching to the same product the knife did not come out halfway.The device was replaced again and the procedure was completed.There were no reports of patient harm associated with this event.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18797900
• Report Number: 9614641-2024-00510
• Device Sequence Number: 12545453
• Product Code: KNS
• UDI-Device Identifier: 14953170208406
• UDI-Public: 04953170208409
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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: 01K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• 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: 07/16/2020
• Initial Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2000
• 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: GIF-Q260J; VIO3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown