MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA TRACHEAL INTUBATION VIDEOSCOPE

Model Number	LF-V
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.The customer¿s complaint was confirmed.A visual inspection was performed on the returned device and found a leak at the bending section glue near tip, bending section cover glue damage, chipped glue around the lens, peeling cement.Based on similar reports, the most likely cause for the reported event is due to user mishandling.The lf-v instruction manual states that ¿do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use this instrument.¿.
Event or Problem Description
The manufacturer was informed that during a therapeutic coronary artery bypass graft, lima (left internal mammary artery), rima (right internal mammary artery), radial, a small piece of rubber from the distal end of the scope fell inside the patient¿s lung.The anesthesiologist was checking the placement of the tube when the reported event occurred.The device fragment was retrieved using the suction of a different scope.It is unknown if the intended procedure was completed.There was no patient injury reported.Additionally, the device was inspected prior to use with no observed abnormalities.

• Brand Name: VISERA TRACHEAL INTUBATION VIDEOSCOPE
• Common Device Name: TRACHEAL INTUBATION VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9458963
• Report Number: 8010047-2019-04285
• Device Sequence Number: 3080742
• Product Code: EOQ
• UDI-Device Identifier: 04953170156250
• UDI-Public: 04953170156250
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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-V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR