MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "LF-GP", SET E; TRACHEAL INTUBATION FIBERSCOPE

Model Number	LF-GP
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during an unspecified thoracic procedure using a lf-gp fiberscope, had a piece of the insertion tube break off into the patient's larynx during a procedure and had to be retrieved.The intended procedure was completed.No further consequences to the patient have been reported.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.The device was returned to olympus for evaluation.The insertion portion was inspected under a microscope and found approximately 50 percent of the bend section cover glue was detached on the insertion tube side.The missing portion was returned with the physical device.

• Brand Name: FIBERSCOPE "LF-GP", SET E
• Common Device Name: TRACHEAL INTUBATION FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; tokyo-to, hachioji-shi 192-8 507; JA 192-8507
• MDR Report Key: 15095583
• Report Number: 2429304-2022-00004
• Device Sequence Number: 5196840
• Product Code: EOQ
• UDI-Device Identifier: 03701354402003
• UDI-Public: 03701354402003
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2022
• Report Date (Section F): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown