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 to olympus for evaluation and the customer's allegation of an air/water leak was confirmed.The device evaluation found the following reportable malfunction: connecting tube had coating peeling (1mm2 or more).The evaluation also found the following non-reportable malfunctions: water tightness was lost due to a pinhole on bending section cover, water tightness was lost due to deformation of control unit, water tightness was lost due to deformation of scope cover, connecting tube had a scratch, connecting tube had a dent, image guide bundle had significant breakages, angulation lever had a scratch, up/down angulation lever plate had a scratch, indication on up/down angulation lever plate was peeled, grip had a scratch, diopter ring had a scratch, connecting tube had a buckling, eyepiece had a scratch, scope cover had a scratch, control unit had a scratch, light guide lens had discoloration, adhesive around objective lens had corrosion, channel cleaning brush cannot be inserted smoothly due to damage on channel tube, angulation lever did not move smoothly due to damage, bending angle in up direction does not meet the standard value due to wear of angle wire, connection between bending section and connecting tube was detached due to deformation of bending tube, eyepiece was loose, and adhesive on bending section cover had a chip.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the tracheal intubation fiberscope had an air/water leak.It was unknown when the issue was found.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: connecting tube had coating peeling (1mm2 or more).There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial medwatch report and 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.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is likely the coating was peeled due to stress of repeated use, external factors, or handling of the device.However, a conclusive root cause could not be determined.The device's instruction manual provides the following warnings which may help to detect the issue: ¿chapter 3 preparation and inspection section 3.2 preparation and inspection of the endoscope inspection of the endoscope 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¿ 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: 18237434
• Report Number: 9610595-2023-18382
• Device Sequence Number: 3227264
• Product Code: EOQ
• UDI-Device Identifier: 04953170061998
• UDI-Public: 04953170061998
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 11/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2000
• 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