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

Model Number	LF-GP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the tracheal intubation fiberscope had a cracked lens.During inspection and evaluation, the image guide coil/snake tube coating peeling.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during incoming inspection and evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: due to a pinhole on connecting tube, water tightness is lost, due to a pinhole on channel tube, water tightness is lost, adhesive on bending section cover has a crack and chip, connecting tube has a wrinkle, due to wear of angle wire, bending angle in up direction does not meet specification, light guide bundle is slipping down, light guide lens has a chip, control unit is sticky due to water leakage, up/down plate is sticky, image guide bundle has a stain, connecting tube has a dent, control unit is sticky due to water leakage, eyepiece has a scratch, and indication on light guide connector is unclear.The investigation is ongoing.A supplemental report will be submitted upon the investigation's completion or if the user facility provides any additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, it is likely that the defect was caused by stress of repeated use, external factors, or handling.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event can 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." 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: 16452082
• Report Number: 9610595-2023-03379
• Device Sequence Number: 14911597
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 01/29/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2017
• 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