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

Model Number KD-611L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned.This report is linked to the following patient identifiers: (b)(6) should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during a therapeutic endoscopic submucosal dissection a perforation occurred in the stomach.The hole was closed with a paper clip and the procedure was cancelled.The patient is under observation.The doctor did not say it was a device malfunction.The patient was hospitalized and is under observation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, since the device was not returned to olympus, a physical device evaluation was not performed.Therefore, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿prepare appropriate hemostasis devices such as clips in case of perforation.Surgical backup should be available in the event of a perforation that cannot be controlled endoscopically.¿ ¿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.¿be sure to check the output power of the electrosurgical unit before use.If the unit is used without the proper output setting, perforation, hemorrhages, or mucous membrane damage may result.¿ ¿do not set the output value of the electrosurgical unit too high or too low.Also, do not allow the activation time to be too long or too short.Set the high-frequency output mode of the electrosurgical unit optimally according to the conditions of the tissue to be cut.An excessive or insufficient output value may result in perforation, bleeding, mucous membrane damage or thermal injuries to the non-target tissue.¿ ¿when an irregularity is detected during use of this instrument, do not continue to use the electrosurgical knife anymore.Otherwise, perforation, hemorrhages or mucous membrane damage may result.¿ ¿this instrument can be incised by both the cutting knife and the electrode.When incising the tissue by pressing the knife forcefully more than necessary, unintended incision may occur by the electrode part, and it may cause perforation and massive bleeding.Always confirm the direction of incision and do not incise with more pressure than necessary.¿ ¿do not force the cutting knife against tissue with excessive force while activating output.Otherwise, unintended resection, perforation and bleeding may occur.When resecting tissue, always confirm the direction of resection and use the instrument without excessive force.¿ ¿do not resect tissue too deep.Deep resection of tissue may cause bleeding, perforation, pneumomediastinum and/or aerodermectasia during or after the procedure.When resecting tissue, confirm that there is no irregularity in the resecting area and monitor the patient¿s condition all the time.¿ this supplemental report includes a correction to g2 and h8 from the initial medwatch.Olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18793816
• MDR Text Key: 336395653
• Report Number: 9614641-2024-00494
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: KD-611L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: FD-410LR; WA90150J
• Patient Outcome(s): Hospitalization; Required Intervention