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

Model Number	FB-19K-1
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device inspection, the biopsy forceps exhibited problems caused by improper reprocessing (foreign matter).There were no reports of patient involvement.Additional details relating to the patient and the event have been requested, but no response has been received at this time.
Additional Manufacturer Narrative
Establishment name should reflect "olympus".This supplemental report is being submitted to provide additional information based on the legal manufacturer¿s evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation results, it is likely that the lubricant was not applied properly, and some foreign materials remained because the appropriate reprocessing was not performed according to the instruction manual.Such events can be prevented by following the instruction for use (ifu).This instruction manual contains the following information.- before use, check that there is no corrosion (tiny holes, dents, discoloration) at the tip and that the cup can be opened and closed smoothly.If biopsy forceps with a corroded tip or biopsy forceps that do not open and close smoothly are used, parts may fall off or the cup may not be able to be opened or closed.If a part falls off during use or the cup cannot be opened or closed smoothly, immediately stop using the endoscope and pull it out, taking care not to damage the body cavity.In addition, use grasping forceps or similar to retrieve any parts that have fallen off.After use, do not leave the product dirty, but wash it immediately.Use a low-foam, neutral detergent for medical equipment to clean it.Leaving the product dirty after use or using an unspecified detergent may cause corrosion of the metal parts such as the cup, which may cause parts near the cup to fall off during use or make it impossible to open or close the cup.- before use, confirm that the distal tip of the forceps is not corroded, dented or discolored, and that the cups can be opened and closed smoothly.Using forceps that are damaged or not working properly may result in one or more of its components falling off inside the patient.If a component falls off the distal end, or if operation of the cups suddenly becomes more difficult, immediately stop the procedure.Carefully withdraw the forceps together with the endoscope to avoid causing injury within the body cavity.Retrieve any parts that have fallen off inside the patient using another grasping forceps.Reprocess the instrument immediately after use by immersing it in a neutral, low-foaming, medical-grade detergent solution, then following the cleaning and sterilization procedures in this chapter.Failure to reprocess the instrument immediately after use, or using another type of detergent may cause corrosion at the instrument¿s distal end.This could cause components to fall off during use and may interfere with operation of the cups.Lubricant application 1.Immerse the tip of the insertion tube and the insertion tube in the lubricant in the lubricant soaking container for 2 to 3 seconds.2.Remove the biopsy forceps from the lubricant.3.Move the slider back and forth to open and close the cup a few times.4.Wipe the exterior surface of the biopsy forceps with clean, dry gauze.Lubrication 1.Immerse the insertion portion in the lubricant for 2 to 3 seconds.2.Remove the instrument from the lubricant.3.Operate the slider to open and close the cups two or three times.4.Wipe the exterior of the instrument with a clean, dry lint-free cloth and allow the instrument to air dry.Olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: 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: 19816380
• Report Number: 9614641-2024-01497
• Device Sequence Number: 12931515
• Product Code: EOQ
• UDI-Device Identifier: 04953170029608
• UDI-Public: 04953170029608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: FB-19K-1
• Device Lot Number: K3Y07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown