MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "ENF-GP"; RHINO-LARYNGOFIBERSCOPE

Model Number ENF-GP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts were made to obtain additional information from the user facility and provide instructions in the proper reprocessing steps of the scope.To date, no response from the user facility has been received.The scope instructions for use (ifu) does not provide instructions for the use of "sheaths instead of cold liquid sterilization" in the reprocessing procedures.Per the ifu, "use basins which are at least 40 cm by 40 cm in size and deep enough to allow the endoscope to be completely immersed." for high level disinfection, "fill a basin with disinfectant solution at the temperature and concentration recommended by the disinfectant manufacturer.Use a basin which is at least 40 cm by 40 cm in size and deep enough to allow the endoscope to be completely immersed.Immerse the endoscope in disinfectant solution.If air bubbles adhere to the surfaces of the endoscope, remove them using a clean lint-free cloth.Cover the basin with a tight fitting lid to minimize the release of disinfectant vapor.Soak the endoscope for the amount of time and at the temperature recommended by the disinfectant manufacturer." in addition, the ifu provides the following warning statement: "all disinfection steps should be performed with the endoscope and all equipment completely immersed.If the equipment is connected or disconnected while not immersed, disinfectant solution may not adequately contact all surfaces of the equipment.As a result, the effectiveness of disinfection may be reduced.".

Event Description

A user facility reported to olympus using "sheaths instead of cold liquid sterilization" in the reprocessing of their olympus fiberscope.There was no patient injury and no patient involvement associated with the issue as reported by the user facility.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the device history record (dhr) review and legal manufacturer's investigation result.The dhr was reviewed for the subject device.No anomalies were noted and it was verified the device was manufactured in accordance with documented specifications and procedures.The legal manufacturer performed an investigation and determined the customer made an inquiry to confirm the cleaning, disinfection and sterilization (cds) of olympus equipment against covid-19.The legal manufacturer's investigation determined there was no user error or a malfunction related to cds against covid-19.

• Brand Name: FIBERSCOPE "ENF-GP"
• Type of Device: RHINO-LARYNGOFIBERSCOPE
• 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: 10011401
• MDR Text Key: 208403551
• Report Number: 8010047-2020-02414
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-GP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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