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

Model Number	LF-DP
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, and the customer¿s allegation was confirmed due to a pinhole on the connecting tube.In addition to the image guide corrugated tube had coating peeling due to deterioration, the additional evaluation findings are as follows: due to damage on the channel tube, channel cleaning brush could not be inserted smoothly; control unit was damaged; due to damage on the image guide bundle, the image had a stain; connecting tube had a dent; and the venting connector under the grip is shaved.The following device components were scratched: control unit, connecting tube, eye piece, diopter, scope cover, grip, up/down plate, and the angulation lever.The event can be detected/prevented by following the instructions for use which state: 1.Visually inspect the control section for excessive scratching.2.Visually inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.3.Visually inspect the surface of the insertion tube for dents, bulges, swelling, peeling or other irregularities.4.Carefully run your fingertips over the entire length of the insertion tube.Inspect for any protruding objects or other irregularities.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, the root cause of the event was unable to be identified; however, the event most likely occurred due to stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that the tracheal intubation fiberscope had leakage from near the operation part.There was no patient harm associated with the event.The device was returned and evaluated, and the image guide corrugated tube had coating peeling.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17347203
• Report Number: 9610595-2023-10283
• Device Sequence Number: 6524615
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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: 06/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2007
• 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