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

Model Number	KD-612L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the tip was detached.The dislodged tip-tip was also sent and cracked, but adhesive was applied to connect the tip, and there was no problem with the amount of adhesive applied.The area near the knife electrode was covered with burnt foreign matter and there were no other abnormalities in the insertion area.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause of the insulating chip detaching could not be determined, likely factors causing the defect could have been the following: 1)due to the factor described below, spark discharge between the tissue and the electrode occurred during output activation.·the high-frequency output was set too high.The output setting for activation was too high.·the electrosurgical unit was used in the coagulation mode.·the output activation time was too long.2) 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.3) a force to exchange the device was applied to the tip.Due to the description stated above 2, the adhesive strength of the adhesive agent decreased causing the tip detachment.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following ifu: ·in rare cases, the tip and electrode may chip or fall off, or the incision knife may deform or break, depending on the conditions of use, such as when the high frequency ablation power supply is used in coagulation mode, when the output setting is high, when the energization time is long, or when the contact length between the tissue and incision knife is short.Always check for any abnormality in the tip during use.If the tip or electrode is found to be chipped or detached, or the incision knife is broken, immediately stop using the knife and use a spare hf knife.Use of an abnormal hf knife may lead to perforation or major bleeding.In addition, the dislodged tip, electrode, and incision knife should be retrieved using grasping forceps.Any mucus or other liquid adhering to the electrode, incision knife, tubing, or tissue in the body cavity must be aspirated.Energizing the device without aspirating the mucus or other liquid may cause perforation, severe bleeding, damage to the mucous membrane, or burns to tissues that are not the target of the incision.If the electrode and incision knife are energized while floating above the tissue to be incised without aspirating the mucus or other liquid, discharge is likely to occur, which may result in the tip chipping or falling off, or deformation or rupture of the incision knife.Do not set the output setting of the high-frequency ablation power supply higher or lower than necessary.Also, do not prolong or shorten the energizing time longer than necessary.Excessive or inadequate energization may lead to perforation, major bleeding, mucous membrane damage, or burns to tissue that is not the target of the incision.The output setting and energizing time should be set appropriately according to the condition of the tissue to be incised.In addition, use of high voltage waveforms increases the likelihood of tip chipping or falling off and deformation or breakage of the incision knife.Use high voltage waveforms only to the minimum necessary.The strength of voltage for each waveform of the high-frequency ablation power supply is as follows.Incision wave/soft coagulation wave < mixed wave < coagulation wave < spray coagulation wave*1 (apc mode, etc.).*1: spray coagulation cannot be used with this product.Do not use excessive force to remove tissue attached to the tip.Also, do not remove tissue adhering to the incision knife by abruptly or continuously thrusting it out or storing it.Rubbing the tip strongly with tweezers or attempting to remove adhered tissue by rapidly or continuously thrusting or storing the incision knife may cause excessive stress on the tip, which may result in chipping or loss of the tip, deformation or breakage of the incision knife.Do not insert the endoscope forcibly, with the incision knife protruding, or rapidly.There is a risk of sudden protrusion from the tip of the endoscope, which may lead to mucous membrane damage, bleeding, etc.If insertion is difficult due to high resistance, return the angle of the endoscope to a point where it can be inserted without difficulty.Forcing insertion while the endoscope angle is greatly curved may cause excessive load on the tip, which may result in cracking of the tip or other product damage.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, that during the esd (endoscopic submucosal dissection) procedure, the electrosurgical knife kd-612 insulating chip at the tip fell off inside the body.The procedure was successfully completed by replacing it with a new product.There were no reports of patient harm or injury.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18841276
• Report Number: 9614641-2024-00579
• Device Sequence Number: 7181113
• Product Code: KNS
• UDI-Device Identifier: 04953170453922
• UDI-Public: 04953170453922
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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-612L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• 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
• Patient Sex: Unknown