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

Model Number KD-611L

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

E1 : the name of the organization is reported as : (b)(6) medical center.Two devices were returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the tip of the first knife was broken and part of the tip had come off the electrode.The tip that came off was not returned.The tip of the second knife was broken as well and had come off the electrode.The tip of the second knife was also not returned, and foreign matter was attached to the tip and electrode.After the foreign matter was removed, the tip was found partially melted.The dhr with the lot number of the subject device was reviewed.No abnormalities detected in the device history record for the following items which related to the reported phenomenon.It has been 6 months since the device was manufactured.Based on the results of investigation, the likely mechanism causing the tip detachment could be 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 might have been locally applied to the electrodes and tip.The tip melted and cracks developed.The fixing strength of the adhesive securing the chip decreased.3)a force to perform tissue incision was applied to the cracked area, causing the tip to crack and detach.However, the exact cause of spark discharge generation could not be identified.Therefore, the root cause of the reported event could not be determined.This issue is addressed in the instructions for use (ifu): this instruction manual contains the following information.(drawing no.Gk6202 revision no.18) 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.

Event Description

The olympus employee reported that during therapeutic endoscopic submucosal dissection, two kd-611l knife tips failed.In the middle of the procedure, the first single use electrosurgical knife tip detached and fell inside the stomach, which was not retrieved.The device was replaced with a similar one and the procedure was completed with this replaced device, which was reported to be slightly chipped at the end of the procedure.No extended hospital stays, procedure prolongation or additional sedation was reported.No diagnostic or medical interventions were undertaken to retrieve the fallen device.No health hazards have been reported and the patient is not having any problems.The event is described under 2 patient identifiers below for 2 single use electrosurgical knives tip defects that occurred during a single therapeutic endoscopic submucosal dissection.1) related patient identifier # complaint # (b)(4); single use electrosurgical knife; model: kd-611l; serial # (b)(6)- the device was slightly chipped at the end of the procedure.2) related patient identifier # complaint # (b)(4); single use electrosurgical knife; model: kd-611l; serial # (b)(6) (this report, the device fell off and was not retrieved).

• 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: 17862499
• MDR Text Key: 324823564
• Report Number: 9614641-2023-01453
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170225963
• UDI-Public: 04953170225963
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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: 34K27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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
• Treatment: SINGLE USE ELECTROSURGICAL KNIFE - LOT 34K24
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male