MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. TRACHEAL INTUBATION FIBERSCOPE

Model Number	LF-DP
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the evaluation it was observed that residual liquid or foreign material in the forceps channel.This finding was due to insufficient cleaning of the scope or handling problem.Upon further inspection, it was observed that water tightness was lost due to a pinhole on the connecting tube.It was also observed that the bending angle in the up direction did not meet the standard value due to wear of the angle wire.It was observed that the image guide bundle had significant breakages due to physical stress.It was also observed that the image had a stain due to damage on the image guide bundle.It was observed that the connecting tube had a dent due to physical stress.Lastly, scratches were observed on the following unit components due to physical stress caused by a handling problem: connecting tube, eyepiece, control unit, scope cover, angulation lever and on the up-down plate.Due to the nature of this reportable event, the customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer cleaned, disinfected, and sterilized the equipment prior to requesting repair.The customer confirmed that the facility does not delay the start of precleaning on the equipment after use.During the precleaning process, the customer supplies air and water through the nozzle.The customer submerges the endoscope in cleaning fluid.The customer flushes the air and water nozzle with detergent solution.The customer confirmed that the facility wipes or brushes the air and water nozzle with a gauze, brush, or sponge.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus the tracheal intubation fiberscope suction channel is clogged.There was no patient/user harm or injury reported due to the event.
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 over 6 years since the subject device was manufactured.Based on the results of the investigation, it is likely residual liquid or foreign material in the instrument channel occurred due to insufficient cleaning of the scope or handling problem.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿ 1.Visually inspect the control section for excessive scratching. 1.Insert a syringe filled with sterile water into the biopsy valve and depress the plunger.2.Confirm that water is emitted from the distal end of the endoscope.¿ olympus will continue to monitor field performance for this device.

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• Common Device Name: TRACHEAL INTUBATION FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16595165
• Report Number: 9610595-2023-04869
• Device Sequence Number: 4474618
• Product Code: EOQ
• UDI-Device Identifier: 04953170136856
• UDI-Public: 04953170136856
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981543
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: LF-DP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2001
• 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