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

Model Number KD-611L

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2020

Event Type  Injury  

Event Description

It was reported during an endoscopic submucosal dissection (esd) procedure, the tip chips fell into patient.The fallen chips were recovered, the device was replaced and the procedure was completed.There were no reports of patient harm associated with this event.

Manufacturer Narrative

The device was returned for evaluation, however; the detached tip was not.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 tip detachment could not be determined, likely factors causing the defect could have been the following: 1) due to the factors 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 : "-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." 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.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: 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: 18702070
• MDR Text Key: 335349402
• Report Number: 9614641-2024-00372
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-611L
• Device Lot Number: 9XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention