MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problem Material Frayed (1262)

Patient Problem Injury (2348)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(b)(4) evaluated the subject device and confirmed that the elevator wire of the device was frayed and bent.Omsc reviewed the manufacture history of the device and confirmed no irregularity.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 during an endoscopic retrograde cholangiopancreatography, the user facility recognized that the elevator wire of the subject device broke and the elevator wire injured a part of esophagus of the patient when the subject device was withdrawn from the patient.The procedure was completed with the subject device.There was no report of further detailed information associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation confirmed that the elevator wire of the device was frayed and bent.As a result of analysis for the fracture surface of the elevator wire, it is surmised that the wire frayed due to fatigue fracture by repeated stress.The instruction manual of the device has already warned as follows; the elevator wire at the distal end is any damage (broken, frayed, or bent), not only the equipment does not function properly but also the broken elevator wire may compromise patient, operator, or other medical personnel safety.When attaching the distal cover, make sure to confirm that the portion of the elevator wire at the distal end is not broken, frayed, or bent.Otherwise, the broken elevator wire may cause injury.Also, if the broken elevator wire is deformed, it may compromise patient, operator, or other medical personnel safety.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8234855
• MDR Text Key: 132763370
• Report Number: 8010047-2019-00827
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other