MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGO VIDEOSCOPE; FLEXIBLE VIDEO LARYNGOSCOPE

Model Number ENF-V3

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report the user's experience and investigation findings.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00410.Physical evaluation of the suspect device: olympus performed an inspection on the ¿as received¿ condition; the scope was attached to a regulated airline at 7.1psi.The scope was dunked inside the water tub where bubbles are observed coming from the bending section cover.The bending section cover was tape to seal the leak and the leak test continue; no other leaks were observed.The bending section cover was observed under the microscope and 2 small tears are noted about 2mm from the distal end cover.In addition, the bending section cover, bending section glue, distal end and insertion tube was wiped down and was not catching cotton, and no metal is exposed.Further findings: olympus observed peeling glue around the objective lens, lifted non-olympus glue at both the insertion tube and distal end side of the bending section cover.Insertion tube had multiple dents.Additionally, cosmetic defects are noted on the labels and angulation is out of olympus standards.The videoscope was purchased on 31march2021 and has not been sent in for previous repairs since purchased.Since the purchased event, the scope has accumulated approximately 430usage/6415mins.Olympus was able to duplicate user report of fluid leak due to holes and lifting in the non-olympus adhesive rubber.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.[conclusion] it was not possible to definitively identify the root cause of the event.Points of consideration from the investigation findings: (1)air leakage might have occurred because rubber a had been damaged, but it could not be determined what caused rubber adhesive to break.·it was confirmed that air leakage was occurring from rubber adhesive.·it was confirmed that there was repair by the third party in the a rubber adhesive.

Event Description

The customer reports during reprocessing of a rhino-laryngo videoscope, leaking was found at the bending section.Prior to reprocessing, the scope was used in an unspecified procedure.It is reported the patient experienced an unspecified injury during that procedure.Additional details have been requested, at this time, no additional information has been provided.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO LARYNGOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14515460
• MDR Text Key: 292733391
• Report Number: 8010047-2022-08941
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170310416
• UDI-Public: 04953170310416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2022

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
• Device Operator: Health Professional
• Device Model Number: ENF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other