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

Model Number	FB-230U
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
A user facility reported to olympus that while using a disposable biopsy forceps to obtain a tissue sample during esophagogastroduodenoscopy, the surgeon complained about the jaw not being sharp.This caused a bad cutting border.Additionally it tore tissue and bleeding occurred (stated to be "a few").Additional information regarding interventions and outcome was requested multiple times without response.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, since the subject device was not returned for an evaluation, the root cause of the reported event could not be determined.However, as reported, the nurse likely assumed that the device (fb-230u) was not sharp enough and may have torn the patient's tissue resulting in the bleed.It was determined that an abnormality of the device was not the cause of the reported event.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not force the distal end of the insertion portion against body cavity tissue.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.¿ ¿biopsy may cause bleeding.If you take a large sample or press the instrument¿s distal end against tissue excessively, the risk of bleeding will increase.Perform biopsy on minimum necessary spots only.¿ although the subject device was manufactured in august 2022, the specific date is unknown.Olympus will continue to monitor field performance for this device.

• 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
• 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: 16482176
• Report Number: 9614641-2023-00311
• Device Sequence Number: 17426562
• Product Code: FCL
• UDI-Device Identifier: 04953170031120
• UDI-Public: 04953170031120
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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-230U
• Device Lot Number: 28T
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/08/2023
• 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