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

Model Number JF-260V

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation and checked the subject device.There were no scratches, holes, or clogging with the foreign objects inside the subject device, but it was found the dent at 5cm instrument channel of the bending section from the distal end of the subject device.Also it was test with running inside the subject device with the cleaning brushes, bw-412t which is same model of user use, and bw-20t.The brushes run smoothly.The dent of the instrument channel of the bending section was surmised that might have occurred due to excessive bending stress apply to the bending section of the subject device, not the endotherapy instruments.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause has been under investigation, therefore 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

Olympus medical systems corp.(omsc) was informed from the user that it was found a stent came out from the instrument channel of the subject device when the forceps was withdrawn at almost end of the unspecified procedure.It must have been a stent which had been lost since last procedure with the subject device.The procedure was completed with the subject device.The user was supposed to implant the non-olympus stent into the patient, however the user missed the stent and confirmed that there was not the stent in the patient by x-ray.Therefore the user supposed that the stent remained in the subject device and the stent would be removed during the reprocessing.However the reprocessing stuff could not found the stent and the stent was not removed during the reprocessing.There was no report of patient injury associated with this event.

• 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: 10867586
• MDR Text Key: 225940676
• Report Number: 8010047-2020-09150
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/19/2020

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: 11/04/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2018
• 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