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

Model Number	FD-412LR
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an endoscopic submucosal dissection (esd) procedure, the single use electrosurgical hemostatic forceps could not be energized, and bleeding could not be stopped and cauterization could not be achieved, even after the device output was increased therefore, a hemostatic clip (under endoscopic guidance) was used to stop the bleeding, and procedure was completed.There was no health damage to the patient.
Additional Manufacturer Narrative
E1: complete establishment name is noted below due to character imitation bizen city national health insurance municipal hinase hospital the device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (g2) and to provide an update to fields (d4-lot number, h3 and h4).The device was evaluated by olympus.And no reportable malfunctions were found, that could have led to the reported event.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 is likely, the reported event occurred, due to the following factors.Adhesion of tissue or other foreign materials to the distal end had reduced the high-frequency current density.The treated area possibly had contained high moisture content such as mucus or blood.Therefore, the high frequency current density had decreased.However, a specific root cause of the reported event could not be identified.The event can be prevented, by following the instructions for use, which state: "before use, prepare and inspect the instrument and a cord as instructed below.Should the slightest irregularity be suspected, do not use the instrument or a cord.Use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforation, bleeding, mucous membrane damage or thermal injury and may result in more severe equipment damage"."aspirate fluids such as mucus that adhere to the tube and body cavity tissue.Patient injury such as perforation, bleeding, mucous membrane damage and thermal injury of tissue could result if output is activated with these fluids adhering".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: 19097286
• Report Number: 9614641-2024-00904
• Device Sequence Number: 12664329
• Product Code: KNS
• UDI-Device Identifier: 04953170359804
• UDI-Public: 04953170359804
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FD-412LR
• Device Lot Number: 31K06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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: ELECTROSURGICAL GENERATOR ESG-100, SN UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown