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

Model Number GIF-HQ190

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history 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

Olympus medical systems corp.(omsc) was informed that during diagnostic procedures, gastrointestinal wall of three patients were damaged and the wall bled when the subject device contacted to the wall.It was also reported that after procedures, the user facility found that the bending section of the subject device did not angulate enough.The procedure were completed with the subject device.Other detailed information was not provided.This is 1 of 3 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional patient information and outcome of the patient.Olympus followed up with the user facility.The user facility reported that there was no health hazard other than the gastrointestinal wall damage and the patient was discharged on the same day that the patient underwent the procedure.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code" and "pma/510(k) number".

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8273096
• MDR Text Key: 133932194
• Report Number: 8010047-2019-00933
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 51