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

Model Number	TJF-Q190V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.On february 22nd, 2019 and march 1st, 2019, olympus representative visited the user facility for training.During the training, olympus representative concluded that the user facility did not attach the distal cover to the subject device properly.The instruction manual describes how to attach the single use distal cover using the figures.Omsc reviewed the manufacturing history (dhr) of the subject 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 or Problem Description
On may 28th, 2019, olympus (b)(4) received a letter associated with this event from competent agency of (b)(6) and was informed that the single use distal cover detached from the subject device fell into the patient¿s stomach during the biliary catheterism.The distal cover was retrieved from the patient body using unspecified fiberscope and foreign body extractor.As a result, the administration time of general anesthesia for the patient was prolonged.There was no report of further patient injury with the event.It was reported that the distal cover was not kept by the user facility.The user facility had asked olympus to provide training on how to install the distal cover.

• 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: 8730287
• Report Number: 8010047-2019-02277
• Device Sequence Number: 1164178
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/25/2019
• 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