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

Model Number	FB-21K-1
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not be returned for evaluation.Additional information has been requested regarding this event and the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
An olympus representative reported to olympus, on behalf of the customer, that the reusable biopsy forceps was reprocessed without using an ultrasonic cleaner as required.Instead, the forceps was reportedly immersed in endofresh and then in glutaraldehyde.It was confirmed that the user facility knew that the device needed to be cleaned by implementing ultrasonic cleaning.There was no patient involvement as the issue occurred during reprocessing.
Event or Problem Description
Additional information was received from an olympus representative indicating that the customer had initially reported that the cups of the reusable forceps had been difficult to open.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from an olympus representative as reported on b5 and based on the legal manufacturer's final investigation.The device was not returned to olympus for investigation and therefore, the reported event could not be confirmed.The date of the event and lot number was unknown.Therefore, a review of the device history record (dhr) for 1zk~2yk for over the past year prior to the date of occurrence was inspected which found no deviations that could have caused or contributed to the reported issue.The instruction manual ((b)(4)) contains the following description which relate to the reported event: "this instruction manual contains essential information on using this instrument safely and effectively.Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the instruments as instructed.Keep this and all related instruction manuals in a safe, accessible location.After using this instrument, reprocess and store it according to the instructions in chapter 4, ¿reprocessing¿ and chapter 5, ¿storage¿.Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.The medical literature reports incidents of patient cross contamination resulting from improper cleaning or sterilization.It is strongly recommended that reprocessing personnel have a thorough understanding of and follow all national and local hospital guidelines and policies.All individuals responsible for reprocessing should thoroughly understand: your institution¿s reprocessing procedures.Occupational health and safety regulations.National and local hospital guidelines and policies.The instructions in this manual.The mechanical aspects of endoscopic equipment.Pertinent germicide labeling".Since there are no deficiencies in the care (cleaning/sterilization) methods described in the instruction manual, it is likely that the user did not correctly understand the cleaning/disinfecting/sterilizing (cds) process as the reason why ultrasonic cleaning was not performed.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: 16030577
• Report Number: 9614641-2022-00831
• Device Sequence Number: 18011032
• Product Code: EOQ
• UDI-Device Identifier: 14953170029773
• 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): 02/11/2023

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
• Was Device Available for Evaluation?: No
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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