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

Model Number CHF-B290

Device Problems No Display/Image (1183); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc (olympus medical systems corp) for evaluation.In the evaluation, the reported phenomenon was duplicated and the damage of the ccd of the subject device was confirmed.The damage of the ccd caused the reported phenomenon.Furthermore there was the possibility that damage of the ccd was attributed to the inappropriate handling by the user such as forcible withdrawal of the subject device from the endoscope without the neutral positions of the angulation control knobs.Also omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during the unspecified procedure using with the subject device, the noise appeared on the endoscopic image of the subject device and then the endoscopic image was disappeared.The user changed the procedure to unspecified other procedure and completed.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) was informed that the user had changed the procedure, because the noise appeared on the endoscopic image of the subject device and then the endoscopic image was disappeared.Omsc tried to get the information regarding the changed the procedure, but omsc couldn't get any detailed information such as how changed the procedure from the user.Information is no changed from the previous mdr.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS LUCERA ELITE CHOLEDOCHO VIDEOSCOPE
• Type of Device: CHOLEDOCHO VIDEOSCOPE
• 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: 9380799
• MDR Text Key: 208122740
• Report Number: 8010047-2019-04093
• Device Sequence Number: 1
• Product Code: FBN
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

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: CHF-B290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1