MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-GP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scope was returned to the service center for evaluation.The customer¿s complaint of a leak was confirmed.In addition, a visual inspection found the light guide lens cracked.There were holes in the bending section rubber and cracked glue.The scope¿s bending section was noted to be detached.The content of this complaint will be reviewed by the legal manufacturer for further investigation.
Event or Problem Description
The service center was informed that during reprocessing the scope was noted to have fluid invasion and a leak at the distal end.There was no patient involvement reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Please see the updates.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.The legal manufacturer reported that the most like causes for the reportable event are as follows:.Air/water leakages or fluid invasion.Since a rubber, the light guide lens, and the bending section have been damaged, there is a possibility that some external force was applied to this product.It is presumed that air leakage occurred from a rubber and the light guide lens due to damage at each part.In addition, there is a possibility that damage of each part was caused by aging degradation, but the cause-and-effect relationship is unknown because the repair history of this product cannot be confirmed.There are no similar complaints caused by manufacturing and design, and there is no frequent occurrence.This product was approximately 2 years and 4 months have passed.Chapter 3 preparation and inspection 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 and see chapter 10,¿troubleshooting¿.If the irregularity is still suspected after consulting chapter 10, contact olympus.Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.".

• Brand Name: RHINO-LARYNGOFIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10497041
• Report Number: 8010047-2020-06212
• Device Sequence Number: 19452012
• Product Code: EOB
• UDI-Device Identifier: 04953170318191
• UDI-Public: 04953170318191
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: ENF-GP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1