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

Model Number	FB-210U
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); 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
Additional Manufacturer Narrative
H4: the subject device was manufactured in nov, 2022 based on the provided 3 digit lot information "2yv".This report was submitted by the importer under the importer's report number 2429304-2023-00253.This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to h6 problem code.Multiple attempts were performed to obtain additional information, but no response was received from the customer.The subject device was not retuned.On june 2, 2023, the customer returned an unused device, and it was confirmed that the unused device presented no abnormalities.There are no signs of physical damage or mishandling on the box or to the product itself.Olympus performed a functional check.When manipulating the slider, the jaws opened and closed smoothly and without any restrictions.Jaws are new and intact.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, bleeding was probably caused by a large gnawing of the mucous membrane.Additionally, no abnormalities were detected in the dhr.Therefore, it is determined that abnormality of the device was not the cause of the reported event.It is possible that the forceps did not resect the mucosa well enough and that a large gnawing of the mucosa occurred.The failure of the forceps to firmly resect the mucosa could be due to the following factors: - the approach to the tissue was poor and the tissue was not pressed against the tissue sufficiently.- the tissue was difficult to resect.- the cup did not close completely due to excessive grasping.Since olympus was unable to check the actual product, a specific cause of the problems could not be determined.The event can be detected by following the instructions for use 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." 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: 17498664
• Report Number: 9614641-2023-01138
• Device Sequence Number: 2394897
• Product Code: FCL
• UDI-Device Identifier: 04953170354113
• UDI-Public: 04953170354113
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K955065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/13/2023
• 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: Required Intervention
• Patient Sex: Unknown