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

Model Number ENF-1T10

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The subject devices have not been returned to omsc.Omsc could not review the service and manufacturing records because the serial number of the subject device was not provided from the user facility.It has been determined that the manufacturing of this type of duodenoscope has been discontinued since 2001.As part of the investigation, omsc reviewed all of the complaints, but there was no record associated with the reported event.The exact cause of the reported event could not be conclusively determined.

Event Description

Olympus medical systems corp.(omsc) in order to confirm was informed an adverse event occured when the user facility conducted an intubation procedure for a pediatric patient using the subject device and a non-olympus intubation tube in (b)(6) 2006.The patient reportedly has suffered unspecified permanent damage since the incident.It was also reported that the user facility got sued by the patient and they were asked for the product information on the subject device.Additional information on the adverse event and the after effect of the patient were not provided from the user facility.There is no report of malfunctions on the subject device.The subject device was already discarded at the user facility.

• Brand Name: OES RHINO-LARYNGO FIBERSCOPE
• 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: 8093778
• MDR Text Key: 128025153
• Report Number: 8010047-2018-02263
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/21/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: ENF-1T10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/21/2018
• 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
• Patient Outcome(s): Disability