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

Model Number	FB-21K-1
Medical Device Problem Codes	Device Reprocessing Problem (1091); Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the biopsy forceps cup could not open or close.The event occurred during preparation for use.The intended diagnostic procedure was completed using a similar device.There was no report of patient or user harm associated with the event.During testing and inspection of the returned device, it was discovered that there was foreign material on the device due to lack of proper reprocessing.This medwatch report is being submitted to capture this reportable malfunction which was identified during the evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The customer¿s allegation of the biopsy forceps could not open or close was confirmed.This was due to foreign material adhering to the biopsy forceps.Proper reprocessing was not performed after use, and foreign material remained.Additionally, the following finding was also identified, and is as follows: the cups could not open or close.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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, it is likely lubricant was not applied properly and some foreign materials remained because the appropriate reprocessing was not performed according to the instruction manual.The root cause of adhesion of foreign materials and insufficient lubrication could not be determined.The cup not opening and closing was caused by a combination of adhesion of foreign materials and insufficient lubrication.The event can be detected/prevented by following the instructions for use which state: - "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."."lubrication: immerse the insertion portion in the lubricant for 2 to 3 seconds.Remove the instrument from the lubricant.Operate the slider to open and close the cups two or three times.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: 17495080
• Report Number: 9614641-2023-01131
• Device Sequence Number: 15267317
• Product Code: EOQ
• UDI-Device Identifier: 04953170029776
• UDI-Public: 04953170029776
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: Health Professional
• Device Model Number: FB-21K-1
• Device Lot Number: K3126-5675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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