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
Additional Manufacturer Narrative
This report was submitted by the importer under the importer's report number (b)(4).H4: the subject device was manufactured on nov 2022 based on the provided lot information "2yv".The subject device was not returned for investigation.Therefore, the event was not be able to confirmed.Only unused/new devices still in their original packaging were received.It was observed that the devices came inside a sealed, clear, and sterile package.There were no signs of physical damage or mishandling on the box or to the product itself.A functional check was performed; when manipulating the slider, the jaws opened and closed smoothly and without any restrictions.Jaws are new and intact.Four additional boxes were sent in, all with the same lot number.The device history record was reviewed and no anomalies were found.The instruction manual contains the following descriptions, and it warns against this event.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.The following factors may have caused the event: 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.However, we were unable to identify the root cause of the problem because we were unable to check the actual product.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.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17499527
• Report Number: 9614641-2023-01140
• Device Sequence Number: 11373267
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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