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 to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that the bending section could not be bent in the up direction due to a cut on the angle wire.Additionally, there was a stain on the image causing a reduced image due to damage on the image guide bundle.Upon further inspection, it was observed that the coating on the connecting tube was peeling due to deterioration.It was also observed that water tightness was lost due to a pinhole on the bending section cover and on the channel tube.Also, water tightness was lost due to deformation of the control unit.It was observed that the adhesive of the bending section cover had a chip due to chemical or physical stress.It was also observed that the channel cleaning brush could not be inserted smoothly due to damage on the channel tube.It was observed that the bending tube had a dent due to physical stress.It was also observed that the control unit has discoloration due to chemical stress.It was observed that the eyepiece was loose due to excessive handling stress.It was also observed that the connecting tube had a dent due to physical stress.It was observed that the indication on the light guide connector was unclear due to chemical stress.It was also observed that the venting connector under the grip was shaved due to physical stress caused by a handling problem.Lastly, scratches were observed on the following unit components due to physical stress caused by a handling problem: control unit, eyepiece, connecting tube, angulation lever, up-down plate, grip, scope cover and on the diopter ring.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 had an angulation malfunction and the image was out of focus/ blurry.There was no patient/user harm or injury reported due to the event.Upon device return and evaluation, it was observed that the coating on the connecting tube had peeling which is a reportable event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during 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: 17466004
• Report Number: 9610595-2023-11208
• Device Sequence Number: 2905037
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

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: 07/10/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2013
• 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