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

Model Number TJF-Q190V

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2019

Event Type  Injury  

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 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
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8730287
• MDR Text Key: 149076637
• Report Number: 8010047-2019-02277
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other