MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number	KD-655Q
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	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the single use electrosurgical knife exhibited a situation where the tip of the knife had fallen off inside the body.The tip of the knife was 3mm (sharp).It was unclear where in the large intestine it had fallen off and the doctor chose not to retrieve it.The issue was found during a therapeutic endoscopic sphincterotomy procedure and the procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.It has been one (1) year since the subject device was manufactured.A review of the device history record found no deviations or non-conformities that could have caused or contributed to the reported issue.Based on the results of the investigation, the cutting knife is inferred to have been fractured; however, the root cause could not be identified.During the tissue incision, discharge occurred due to the output setting being high, the coagulation mode being used, and the energization time being prolonged.The high temperature produced by the discharge led to a deterioration in the strength of the cutting knife.The cutting knife, which had reduced strength, was subjected to a tensile load, causing it to thin and fracture at the base.Consequently, the fractured area of the cutting knife assumed a tapered shape.The gloss observed on the fracture surface is concluded to have resulted from friction with another object.The event can be prevented by following the instructions for use which state: (drawing no.Gk9165 revision no.9) 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 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 increases the likelihood that the cutting knife may break.When a high-voltage waveform has to be used, minimize the duration of current application.Electrosurgical unit: voltage intensities of various waveforms.1: 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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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: 19261090
• Report Number: 9614641-2024-01040
• Device Sequence Number: 6519429
• Product Code: KNS
• UDI-Device Identifier: 04953170405631
• UDI-Public: 04953170405631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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-655Q
• Device Lot Number: 42K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROSURGICAL UNIT (ERBE VIO 3 ); EVIS LUCERA ELITE VIDEOCOLONOSCOPE (PCF-H290T)
• Patient Sex: Unknown