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

Model Number ENF-VT2

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 08/23/2020

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the patient had the nasopharyngeal endoscopy with the subject device because the patient had felt the uncomfortable on the throat.During the procedure the user facility found that bending section rubber was broken and the patient suffered the nasal mucosal injury and the hemorrhage.The user facility treated the patient¿s hemorrhage.The user facility did not provide other detailed information such as the patient outcomes.There was no further report of patient injury associated with this event except the reported issue.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Olympus china informed the following additional information.The damage of the bending section rubber was found after the procedure.During the procedure the patient pulled the subject device out of the nose by himself, resulting in nasal bleeding.Then the patient recovered after hemostasis and was discharged from the hospital.The nasopharyngeal endoscopy was postoperative reexamination of laryngeal cancer and treatment of vocal cord polyps.The user refused to send the subject device to olympus china, however the user sent the subject device to the third party for repair.Based upon the information from olympus china, there was the possibility that the reported phenomenon was attributed to the following.Since the patient pulled the subject device out of the nose by himself with excessive force, the excessive stress might be applied to the bending section then bending section rubber might be damaged.Consequently, the mesh inside the bending section might be exposed, then patient¿s nasal mucosa might be injured.However, the exact cause of the reported phenomenon could not be conclusively determined.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11002657
• MDR Text Key: 222762881
• Report Number: 8010047-2020-10323
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ENF-VT2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR