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

Model Number JF-260V

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus medical systems corp.(omsc) for evaluation.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omcs investigated the actual device and stent and confirmed the following; there were no abnormalities such as scratches or clogging of foreign material inside the instrument channel port.There was no abnormality inside the instrument channel and in the branch inside the instrument channel port.The appearance of the stent had bent flaps, wrinkles, and deformation.From the results of checking the actual device, omsc determined that the reported event was not caused by an abnormality in the device.If additional information becomes available, this report will be supplemented.

Event Description

The user facility reported that they suspended a intraluminal ultrasonography because they felt restriction when they were inserting a probe into the instrument channel of this endoscope.The user then checked the inside of the channel and found that a stent remained there.The stent was used for the previous procedure.The user removed the stent and the procedure was completed.There was no report of patient injury associated with the event.The intended procedure for the previous patient was to put a stent in the pancreatic duct stent, but was postponed due to its difficulty.The device had been manually cleaned and then reprocessed using a washing machine.The reprocessing staff did not feel any resistance in inserting a cleaning brush into the channel.The user facility is asking olympus to investigate to find out whether the event was due to the design issue or human factor.

• Brand Name: EVIS LUCERA 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: 11053101
• MDR Text Key: 223064901
• Report Number: 8010047-2020-10798
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2020

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: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2013
• 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