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
Upon evaluation of the returned device, the physical check found no damage.The biopsy cup and blade were dirty.The biopsy cable and sheath, as well as the handle, were all found to be in normal condition.During the functional check, when opening and closing the biopsy cups, they were found to be in a "struck" condition.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 retrieve sample tissue during a colonoscopy, the jaw was not sharp.His caused a bad cutting border.Additionally it tore tissue in the colon and moderate (also reported as "intermediate") bleeding occurred.The bleeding was stopped with multiple clips.Additional information regarding the outcome has been 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.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, since the subject device presented no abnormalities that could have led to the reported adverse event, the root cause could not be identified.Furthermore, as reported, the nurse likely assumed that the device (fb-230u) was not sharp enough and may have torn the patient¿s tissue causing it to bleed.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 injuries, 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.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Also, new information has been added to h4.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: 16483247
• Report Number: 9614641-2023-00318
• Device Sequence Number: 7671395
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2022
• 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 Age: 54 YR
• Patient Sex: Male