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

Model Number	TJF-Q190V
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Injury (2348)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Olympus medical systems corp.(omsc) was informed that during an emergency endoscopic retrograde cholangiopancreatography (ercp) using the subject device, the patient's duodenum was injured and bleeding with a forceps elevator of the subject device.The user facility discontinued the procedure and found that a piece of a duodenum mucous had been trapped in the forceps elevator of the subject device.The user facility rescheduled the procedure.The user facility stated that the patient was fine, the bleeding was stopped and there was no permanent damage.The user facility reported that similar phenomenon with the subject device occurred twice including this event.Therefore, omsc will submit two medical device reports (mdr) depending on the number of adverse events.This report is the second report that occurred on (b)(6) 2020.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The user facility states that the single use distal cover (maj-2315) was attached correctly.Also reportedly, the physician attempted to aspirate the patient's tissue and the tissue became trapped in the forceps elevator.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus europa (b)(4).(b)(4) 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.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.If additional information becomes available, this report will be supplemented.
Additional 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
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9816458
• Report Number: 8010047-2020-01746
• Device Sequence Number: 12920722
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K193182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 05/21/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/03/2020; 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other