MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-210U
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to olympus that during unspecified diagnostic procedures, the disposable biopsy forceps was taking big "bites" out of the mucosa, causing bleeding.The physician was uncomfortable with the large sample.Some of the patients required hemostatic methods such as cautery or clips.The procedures were not delayed due to the issue and the outcome of the procedure was unaffected.This event requires two reports.Patient identifier (b)(6) is for an individual patient.Patient identifier (b)(6) is for "some patient's" of unknown quantity.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 17498586
• Report Number: 2429304-2023-00253
• Device Sequence Number: 6796436
• Product Code: FCL
• UDI-Device Identifier: 04953170354113
• UDI-Public: 04953170354113
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2023
• Report Date (Section F): 05/30/2023

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: FB-210U
• Device Lot Number: 2Y V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown