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

Model Number	FB-19C-1
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.When the slider was operated, the grasping jaws could be opened and closed, but there was a sense of resistance.In addition, there was foreign matter adhered to the arms.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
Event or Problem Description
An olympus employee reported on behalf of the customer, the biopsy forceps cup did not open and close during preparation for use.The subject device was replaced with another device, and the procedure was completed.There was no report of patient harm associated with the event.During incoming inspection, it was determined there was foreign matter adhered to the arms.This mdr is being submitted to capture the reportable malfunctions found during evaluation.
Additional Manufacturer Narrative
Additional information has been received from the customer.This supplemental report is being submitted to provide this information as well as additional information based on the legal manufacturer's final investigation.Please see the updates in sections b5, h6, and h10.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely due to insufficient cleaning or that it has not been sufficiently cleaned due to the passage of time after use.The following information is stated in the instructions for use (ifu): ¿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.¿ ¿when inserting the instrument into the endoscope, hold it close to the biopsy valve or t-plug and keep it as straight as possible relative to the biopsy valve or t-plug.Otherwise, the insertion portion could be damaged.¿ olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer provided additional information: the intended procedure was a therapeutic one for the removal of fish bones.There was no patient harm.The delay in the procedure took about five minutes to change the forceps.It is unknown the extent of sedation.

• 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: 15928615
• Report Number: 9614641-2022-00716
• Device Sequence Number: 19929572
• Product Code: EOQ
• UDI-Device Identifier: 14953170029582
• UDI-Public: 04953170029585
• 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): 01/03/2023

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-19C-1
• Device Lot Number: R5607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/1995
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENF-VT2
• Patient Sex: Unknown