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

Model Number GIF-HQ190

Device Problem Increase in Pressure (1491)

Patient Problem Abrasion (1689)

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, 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 was returned to olympus for evaluation.The evaluation confirmed the reported scope issue.A visual inspection was performed on the scope and found signs of foreign material stuck inside the auxiliary water channel opening causing a blockage and preventing air from escaping the nozzle when water is passed through the water auxiliary inlet port from the scope connector side.The scope was serviced and returned to the user facility.Based on the investigation findings, the cause of the reported event is likely attributed to improper maintenance of the scope.The instruction manual for use provides several statements in an effort to prevent equipment damage and patient injury, ¿before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If the endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.After using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion reprocessing manual.Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance.Be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction.".

Event Description

Olympus was informed that during an unspecified procedure, the water flush was so strong that is resulted in abrasions on the patient¿s stomach lining.The patient¿s outcome is 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6871295
• MDR Text Key: 86418669
• Report Number: 2951238-2017-00627
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• 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
• Device Lot Number: N/A
• Other Device ID Number: 04953170305276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other