MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE DUODENOVIDEOSCOPE

Model Number TJF-Q290V

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/09/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc for evaluation.Since the serial number of this device is unknown and omsc could not confirm the manufacturing history.The exact cause of the reported event could not be conclusively determined because the subject device was not returned omsc for evaluation.

Event Description

Olympus medical systems corp.(omsc) was informed that after an endoscopic retrograde cholangiopancreatography using the subject device, the user facility noticed that the distal cover of the subject device detached from the subject device when the subject device was removed from the patient.It was reported that the user facility considered that the distal cover fell into the patient¿s body and has remained in the patient, but they has decided to leave the distal end cover in the patient.There was no report of further patient injury with the event.

• Brand Name: EVIS LUCERA ELITE 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: 9804342
• MDR Text Key: 222560843
• Report Number: 8010047-2020-01702
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2020

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: Health Professional
• Device Model Number: TJF-Q290V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1