MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGO FIBERSCOPE; RHINO-LARYNGO VIDEOSCOPE

Model Number ENF-GP2

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).The reported malfunction of the angulation system of the device could not be reproduced.The evaluation confirmed that three fibers for transmitting image were broken, which is within the olympus standard.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed of broken image fiber.During an inspection for the subject device by olympus repair center (orc), it was found that the angulation lever got caught on the maximum up angulation.There is no information on whether or not the reported angulation issue occurred during the procedure.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus followed up with the user facility, and the user facility reported that the malfunction of the angulation lever that was found at olympus repair center, did not happened during the procedure.The exact cause of the malfunction could not be determined at present.

• Brand Name: RHINO-LARYNGO FIBERSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8201841
• MDR Text Key: 131904165
• Report Number: 8010047-2018-02592
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

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
• Device Operator: No Information
• Device Model Number: ENF-GP2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1