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

Model Number TJF-Q190V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time, however there was the possibility that this phenomenon was attributed to the user handling.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that user facility performed an ercp procedure with the subject device on a patient.The user facility found that after the procedure (when withdraw the subject device from the patient) a larger piece of mucosal tissue was trapped on the forceps elevator.The user facility stated; the patient was well and that the patient had a small bleeding after the procedure, but it was stopped through the doctor.The ercp procedure could not be completed.The position of the elevator control lever when withdraw the subject device was unknown.Single use distal cover (maj-2315) was attached correctly.

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) but was returned to olympus europa se & co.Kg.(oekg).Oekg checked the subject device, especially the exterior and behavior of the forceps elevator of the subject device, and found that there were no abnormalities that could cause the reported event.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.

Manufacturer Narrative

This supplemental report is being submitted to additional information.Olympus medical systems corp.(omsc) received the subject devices.In addition to the usual investigation, omsc conducted additional investigation from the following viewpoints.Are there any burrs, edges or any irregularity that may cause injury on the outer surface of the subject devices or the forceps elevator? is there any abnormality in the operation or movement of the forceps elevator? is the trapping of the mucous membrane by the forceps elevator reproduced? as a result of investigation, no abnormalities in the viewpoints listed above were found in the subject devices.Regarding the operation or movement of elevator, omsc checked operation force of the forceps lever, position and movement of the forceps elevator lever and rising angle of biopsy forceps, and all the results passed the product standards.In addition, testing was conducted using the forceps elevator and an object simulating the mucous membrane.No trapping of the object occurred during this testing.Olympus has followed up with the user facility multiple times to gather additional information such as additional details about the procedure on the reported events, however the hospital response was unable to provide any additional information.The instruction manual of the subject device states the notice for the appropriate handling of the device.The exact cause of the reported event could not be conclusively determined.

• Brand Name: EVIS EXERA III 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: 9852833
• MDR Text Key: 190942355
• Report Number: 8010047-2020-01825
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2020

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: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 03/24/2020; 05/21/2020
• Supplement Dates FDA Received: 04/03/2020; 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other