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

Model Number	LF-V
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection, that the videoscope forceps plug nozzle was loose.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additional information added to field h6, h3.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 20 years since the subject device was manufactured.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.".Based on the results of the investigation, the customer's reported issue was confirmed.Moreover, it was presumed that an external factor caused the part to get loose or broken, leading to the subject event.However, the definitive cause could not identified.The following is included in the instructions for use (ifu): it was confirmed that instructions for visera tracheal intubation videoscope lf-v chapter 3, ¿preparation and inspection, section 3.2, ¿preparation and inspection of the endoscope¿ describes how to inspect for the subject event.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA TRACHEAL INTUBATION VIDEOSCOPE
• Common Device Name: TRACHEAL INTUBATION VIDEOSCOPE
• 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: 20145997
• Report Number: 9610595-2024-17744
• Device Sequence Number: 18217978
• Product Code: EOQ
• UDI-Device Identifier: 04953170340246
• UDI-Public: 04953170340246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: Other
• Device Model Number: LF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2004
• 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