MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA BRONCHOVIDEOSCOPE

Model Number	BF-1T260
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Hemorrhage/Bleeding (1888); Injury (2348)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4) sales & service co.,ltd.(ocm) for evaluation.The evaluation confirmed a projection on the bending section rubber of the subject device and a air leakage around the projection.In addition, after the disassembling of the bending section rubber, the evaluation confirmed that several metal filaments of the inner parts of the bending section rubber frayed and broke at the leakage point.Ocm reviewed the service (repair) history of the subject and confirmed following repair record by ocm; on (b)(6) 2017, the insertion portion of the subject device was replaced due to an air leakage from the instrument channel, scratches on the insertion portion, and wear and tear of the insertion portion.On (b)(6) 2018, the bending section rubber was replaced due to the leakage from bending section rubber.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.
Event or Problem Description
Olympus was informed that during unspecified transnasal bronchoscopy by the facility, the rhinal mucosa of the patient was injured and had a small amount of bleeding.The procedure was cancelled and the bleeding was treated by astriction using gauze.It was reported that the bleeding stopped five minutes after the astriction and there was no complication related to this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was returned to omsc for evaluation with the bending section rubber removed the device evaluation confirmed that several metal filaments of the inner parts of the bending section rubber frayed and broke.The analysis of the fracture surface on the broke point of the metal filaments indicated that the metal filament possibly broke due to a fatigue by repeated physical stress.The evaluation could not identify when the metal filaments frayed and broke.The instruction manual have already instructed ¿inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.¿ in addition, the instruction manual warns; ¿transnasal insertion is accompanied by the risk of inflammation of the nasal cavity.If this happens, the nasal passage will be constricted, making it more difficult to withdraw the endoscope.In this case, do not use force to withdraw the endoscope because patient injury such as bleeding or perforation may result.¿.

• Brand Name: EVIS LUCERA BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7599661
• Report Number: 8010047-2018-01138
• Device Sequence Number: 12409636
• Product Code: EOQ
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: BF-1T260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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: Other