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 subject device in this report has not been returned to omsc for evaluation.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 the incoming inspection for repair at olympus (b)(4) (oekg), it was confirmed that the elevator wire was broken and the strand of the elevator wire was raised.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, there is a possibility that the reported phenomenon was attributed to long-term repeated use, excessive physical stress due to raising the forceps elevator in conjunction with a non-applicable therapeutic device or insertion/removal of a therapeutic device while the forceps elevator was risen up.

• 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: 11054221
• MDR Text Key: 227388198
• Report Number: 8010047-2020-10811
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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
• Device Operator: No Information
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1