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

Model Number	ENF-P4
Medical Device Problem Code	Failure to Disinfect (1175)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scope was not returned to olympus for evaluation.The olympus fse informed the user facility of the error in their reprocessing and provided a reprocessing manual and literature to assist in reprocessing the scope correctly.The user facility acknowledged and will reprocess the scope correctly moving forward.A review of the scope¿s service records could not be performed as the fse could not confirm the serial number because it was rubbed off.In addition, there are no install base records for this model scope.Subsequently, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a formal reprocessing training.To date, the ess visit has not been finalized.If additional information becomes available, this report will be supplemented accordingly.To mitigate the risk of patient infection, the scopes reprocessing manual provides warning that states, ¿failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety.During use, the instrument normally comes in contact with intact mucous membranes.To minimize the risk of transmitting diseases from one patient to another, after each examination the endoscope must undergo thorough manual cleaning followed by high-level disinfection or sterilization.¿.
Event or Problem Description
Olympus was informed that while performing a clinical demonstration on an automatic endoscope reprocessing machine, the olympus field service engineer (fse) observed the user facility was not performing high level disinfection on the scope.After performing manual cleaning with detergent on the scope, the scope was then being prepared for use.The user facility informed the fse that they were under the assumption that just cleaning the scope was required.There were no patient infections or injuries reported.In additions, there was no malfunctions reported with the scope.There was no culture testing conducted.No additional information was reported by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provided additional information from the olympus endoscopy support specialist (ess).The ess reported that an observation of the user facility's reprocessing practice was not performed, since the ess performed a full reprocessing in-service on the enf and gi scopes showing all steps recommended by olympus including the use of the user facility's new oer pro.The reprocessing manuals, wall charts, attendance sheets and on track were provided to the customer as well as olympus university reprocessing specialist flyer.

• Brand Name: RHINO-LARYNGO FIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8384672
• Report Number: 2951238-2019-00484
• Device Sequence Number: 16687069
• Product Code: EOB
• UDI-Device Identifier: 04953170318207
• UDI-Public: 04953170318207
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K011869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: Other
• Device Model Number: ENF-P4
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1