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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed a literature titled "rebleeding risk of acute hemorrhagic rectal ulcer: a multicenter retrospective study".Acute hemorrhagic rectal ulcer (ahru) is characterized by sudden, painless, and massive bleeding from rectal ulcers.To date, few studies have analyzed the risk factors for ahru rebleeding.In this study, we clarified the risk factors of rebleeding after initial hemostasis of ahru through a multicenter study.Type of adverse events/number of patients.The following events have been reported in the literature.Rebleeding (35 cases).Rebleeding was observed in 35 patients (23%), and the mean time from initial bleeding to rebleeding was 5.2 days.The mean number of episodes was 1.8 times.The maximum number of rebleeding episodes experienced by a patient was seven.One patient with refractory bleeding, in whom hemostasis was unsuccessful, underwent embolization.Multiple hemostatic procedures were performed once in 3 patients (3.6%) using a combination of clips and hemostatic forceps.
Additional Manufacturer Narrative
This report is related to (b)(4).The event date was reported as the publication date of the literature.The evaluation of the event 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.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the reported event is an accident, or a complication associated with a procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.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: 20484626
• Report Number: 9614641-2024-02004
• Device Sequence Number: 3553354
• 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,Study,Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: EVIS LUCERA COLONOVIDEOSCOPE: SN UNK; EVIS LUCERA ELITE COLONOVIDEOSCOPE: SN UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown