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	02/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has not been returned for evaluation.Since the lot number/manufacturing number of the device used is unknown, the manufacturing records cannot be investigated, but olympus conducts inspections and only ships products that pass the inspections.Since there was no mention of a product-related defect in the literature, it is believed that this event was not caused by a defect in the product.It is not possible to identify the root cause of the reported event.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled, "treatment with vonoprazan for 3 weeks is not inferior to 8 weeks for the management of gastric endoscopic submucosal dissection (esd):a multicenter noninferiority randomized study." abstract vonoprazan, a potassium-competitive acid blocker (vpz), significantly reduces postoperative bleeding after gastric esd; however, there is no consensus on the appropriate treatment duration.We conducted a randomized controlled study to demonstrate that the 3-week administration of vpz is not inferior to the 8-week administration for ulcer healing.Type of adverse events/number of patients bleeding n=7.Patient identifiers: (b)(6) :kd-655l.(b)(6) :kd-611l.(b)(6) :fd-410lr.(b)(6) :wb991046 (esg-100).This report is for (b)(6).

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17078892
• Report Number: 9614641-2023-00804
• Device Sequence Number: 2188515
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 05/10/2023
• Initial Report FDA Received Date: 06/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown