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

Model Number	FD-411QR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described a coagrasper, olympus chose fd-411qr as a representative product.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following linked patient identifiers: (b)(6).
Event or Problem Description
Olympus reviewed the following literature titled "the derivation and external validation of a fibrosis risk model for colorectal tumours undergoing endoscopic submucosal dissection." literature summary: this study aimed to derive and validate a prediction model to determine the preoperative degree of submucosal fibrosis in colorectal tumours undergoing endoscopic submucosal dissection (esd).A total of 309 patients (age: 68 ± 10.9 years) underwent colorectal esd.No fibrosis (f0), f1 fibrosis, and f2 fibrosis were reported in 196 (63.4%), 70 (22.6%), and 43 (13.9%) cases, respectively.Complications were experienced in 20 (6.4%) resections, 10 (3.2%) being perforations and 10 (3.2%) significant bleeding.After dissection, hemostasis was performed with a coagrasper whenever necessary, and defects were closed with through-the-scope clips.Type of adverse events/number of patients.Perforation/10 patients.Significant bleeding/10 patients.
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, the reported event was likely an accident, or a complication associated with a surgical procedure while using the subject device.However, there was no complaint reported on the subject device and 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: 20351642
• Report Number: 9614641-2024-01915
• Device Sequence Number: 7931575
• Product Code: KNS
• UDI-Device Identifier: 04953170251535
• UDI-Public: 04953170251535
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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-411QR
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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: CF-HQ190I/UNKNOWN SERIAL #; ELECTROSURGICAL UNIT VIO3 BY ERBE; KD-611L OR KD-612L/UNKNOWN LOT #; KD-650L/UNKNOWN LOT #
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown