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

Model Number	LF-GP
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the complaint was confirmed and water tightness was lost due to a pinhole at the bending section cover and a deformed control unit.Also, evaluation found the light guide lens was broken, the connecting tube was corrugated, the control unit was dirty, the connecting tube was dented, the image was not clear due to a broken image guide bundle, the bending section cover adhesive had a gap, and the objective lens was chipped.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported the insertion part of the tracheal intubation fiberscope was leaking.The issue was found when preparing the scope for use in a diagnostic procedure.The procedure was completed with a similar device.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the coating of the connecting tube was peeled.The report is being submitted due to the peeled coating found during evaluation.
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, a definitive root cause of the observed insertion tube coating peeling could not be determined, however, it is likely that the issue was due to stress resulting from handling, chemical/reprocessing and or storage environment.The event may be prevented by following the instructions for use which state: ¿important information ¿ please read before use: warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient¿.¿1.4 precautions:¿ ¿if cleaning, disinfection and sterilization methods not stated in this instruction manual are performed, olympus cannot guarantee the effectiveness, safety and durability of this instrument.Make sure to confirm that there is no abnormality before use, and use under responsibility of a physician.Do not use if any abnormality is found¿.¿the storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature.Storing the endoscope in direct sunlight, at high temperatures, in high humidity or exposed to ozone, x-rays and/or ultraviolet-rays may damage the endoscope or present an infection control risk.¿.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: 16680321
• Report Number: 9610595-2023-05599
• Device Sequence Number: 18134473
• Product Code: EOQ
• UDI-Device Identifier: 04953170061998
• UDI-Public: 04953170061998
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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-GP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2016
• 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