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

Model Number	FD-410LR
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the hemostatic forceps did not work in the middle of a therapeutic procedure.The intended procedure was a hemostasis undertaken due to lesion in the wall of the upper digestive tract.The hemostatic forceps did not work in the middle of the procedure.The patient experienced loss of fluids/bleeding and anesthesia time was greatly extended.The patient was reported to have a cardiac issue with a cardiac rhythm regulating device (to regulate the heart rate).Also, the lesion was subjected to different type of devices to ensure adequate result.As such, other noninvasive hemostasis methods were used due to patient's condition in consultation with cardiology to complete the procedure safely at a later date.Reportedly the bleeding was able to be controlled, and the intended procedure was cancelled and "resumed" after a few days.The patient's condition is reported as "controlled".
Additional Manufacturer Narrative
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 an update to fields (d4, 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 that the reported malfunction occurred due to the following.- 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, the specific root cause of the reported event could not be determined.The event can be detected/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." "do not pull the cable to unplug the a cord plug or a cord jack.This could damage the a cord." "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: 20702260
• Report Number: 9614641-2024-02094
• Device Sequence Number: 19772314
• Product Code: KNS
• UDI-Device Identifier: 04953170208430
• UDI-Public: 04953170208430
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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-410LR
• Device Lot Number: 3ZK20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/17/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown