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

Model Number TJF-160VR

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus medical systems corp.(omsc) but was returned to ocg for evaluation.The evaluation of the device by ocg confirmed the following; the reported event appeared to be caused by mechanical or chemical stress by repeated use for the long duration.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 inspected the device at the service department of olympus (b)(4) (ocg) and found that some of the wires that composes the forceps elevator wire of the device were broken.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The exact cause of the reported event could not be conclusively determined.From the device inspection result by olympus czech group, s.R.O., olympus medical systems corp.(omsc) confirmed that the forceps elevator wire was partially cut near the forceps elevator.The position where the forceps elevator wire was cut is similar to the similar malfunction event reported in the past.In addition, the cause of similar malfunction event was fatigue failure of the forceps elevator wire due to repeated operations of forceps elevation.Therefore, the omsc concluded that the reported event may have been caused by fatigue failure of the forceps elevator wire due to repeated operations of forceps elevation.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11016775
• MDR Text Key: 227172671
• Report Number: 8010047-2020-10428
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1