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

Model Number GIF-H260Z

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for the evaluation.The exact cause has been under investigation.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 from the user facility that the foreign object had been existed in the auxiliary water channel of the subject device.There was no report of patient injury associated with this event.The user facility did not provide the other detailed information such as when it was occurred.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacture history (dhr) of the device and confirmed no irregularity.Since omsc could not duplicate the reported phenomenon, the exact cause could not be conclusively determined.However, omsc found the white foreign objects on the exit of the auxiliary water channel and around the air/water nozzle of the subject device.They were identified silicate, carbonate, silicon, oxygen, carbon, calcium, magnesium, sodium by analysis.There was the possibility that they derived from tap-water or some agent.Based on those things, omsc surmised it might occurred due to the inappropriate reprocessing.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9976334
• MDR Text Key: 225605601
• Report Number: 8010047-2020-02267
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GIF-H260Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1