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

Model Number GIF-HQ190

Device Problem Material Deformation (2976)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.The scope has not been returned to olympus for evaluation.The cause of the reported device issue could not be determined.As part of our investigation, a review of the device service history was performed and found that the scope was returned to olympus for service on multiple occasions after the scope¿s purchase date of (b)(6) 2013.Most recently, the scope was last serviced on (b)(6) 2018 for a similar issue with the scope¿s angulation of the bending section.Based on similar reports, user handling could not be ruled out as a contributing factor to the reported device issue.The instruction manual for use provides a warning statement in an effort to mitigate equipment damage and patient harm.¿never perform angulation control forcibly or abruptly.Never forcefully pull, twist, or rotate the angulated bending section.Patient injury, bleeding, and/or perforation may result due to unintended retroflexion of the bending section.It may also become impossible to straighten the bending section during an examination.¿ if additional information becomes available or if the scope is returned at a later time, this report will be supplemented accordingly.

Event Description

Olympus was informed that during an unspecified therapeutic procedure, the patient received a small duodenal perforation, likely due to an angulation problem with the scope.It is unknown if the procedure was completed.The patient¿s outcome is also unknown.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fdf to fds and 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: 7550191
• MDR Text Key: 109482032
• Report Number: 2951238-2018-00324
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/03/2019

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: Health Professional
• Device Model Number: GIF-HQ190
• Device Catalogue Number: GIF-HQ190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other