MAUDE Adverse Event Report: OLYMPUS AMERICA, INC EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H190

Device Problems Fluid/Blood Leak (1250); Device Difficult to Setup or Prepare (1487); Pressure Problem (3012)

Patient Problems Exposure to Body Fluids (1745); Unspecified Eye / Vision Problem (4471)

Event Date 12/01/2022

Event Type  Injury  

Event Description

The customer reports during a colonoscopy procedure using an evis exera iii gastrointestinal videoscope and an evis exera iii colonovideoscope, a user experienced a splash injury (eye).Details as follows.The provider was wearing a face shield, and in the process of exchanging an empty water bottle for a new one, sustained a splash exposure from the valves which were well placed.We commonly notice that the change in pressure during the bottle exchange can cause a blow back, which may have happened in this case.Immediate action was rinsing the eye.The patient was hiv+, so operator had to be on anti-retroviral therapy for months after the exposure.The device was inspected prior to use.There were no issues completing the procedure.The patient did fine and was not impacted by the event.Case with patient identifier (b)(6) reports the gastrointestinal videoscope used in the procedure.Case with patient identifier (b)(6) reports the colonovideoscope used in the procedure.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16060160
• MDR Text Key: 306253869
• Report Number: 2429304-2022-00176
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2022,12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention