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

Model Number	FD-410LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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, it was determined, that an abnormality of the device was not the cause of the reported event.However, the root cause could not be identified.The event can be detected/prevented, by following the instructions for use (ifu), which state: ¿use this instrument in an environment equipped to accommodate open surgery.And have the hospitalization plan prepared in case any problem occurs, that may not be resolved endoscopically¿.¿this instrument assumes, that it is used only when the following conditions are met, but it should be noted, that in certain cases, use of this instrument could lead to a surgical operation, perforation or bleeding.Keep this possibility in mind when using this instrument¿.¿this instrument has been designed for use by a physician.The operator of this instrument should deepen the understanding of the clinical procedures by referring to video and other medical materials showing clinical cases.And by receiving sufficient training in training facilities¿.¿this instrument has been designed for use under situations in which, surgical operation is available as an emergency measure¿.¿if you use the instrument several times, during one procedure.Confirm, that there is no irregularity with its operation and appearance, each time you use it.Do not use the instrument if you detect any abnormality.The breakage of the distal end such as the operation wire¿s detachment could cause mucous membrane damages¿.¿be sure to check the output power of the electrosurgical unit before use.If the unit is used without prior output setting, perforation, bleeding or mucous membrane damage may result¿.¿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¿.¿do not apply current, while pressing the instrument against tissue, while the forceps are closed or opened.This may cause patient injury such as perforation, massive bleeding or tissue damage¿.This supplemental report includes a correction to g2 and h6 (type of investigation) from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 18793850
• Report Number: 9614641-2024-00495
• Device Sequence Number: 20668148
• Product Code: KNS
• UDI-Device Identifier: 04953170208430
• UDI-Public: 04953170208430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: FD-410LR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: KD-611L; WA90150J
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown