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 01/21/2019

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Since the information of the serial number of the subject device was not provided, omsc cannot review the manufacturing history of the subject device.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 a diagnostic procedure, the gastrointestinal wall of the patient was damaged and bled when the subject device contacted to the wall.The user facility reported that there was no health hazard by the bleeding so far but gastric ulcer possibly would occur.It was also reported that after the procedure, the user facility found that the bending section of the subject device did not angulate enough.The patient was discharged from the user facility.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental report is being submitted to provide updates.Olympus medical systems corp.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.

• 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: 8342527
• MDR Text Key: 136231331
• Report Number: 8010047-2019-01098
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• 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: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GIF-HQ190
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 02/13/2019; 02/15/2019
• Supplement Dates FDA Received: 03/04/2019; 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 57