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

Model Number GIF-H190

Device Problems Partial Blockage (1065); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.Evaluation determined that the device was found to have foreign object on the channel.Biopsy was found leaking and the ¿a-rubber¿ glue was found worn out.Objective lens were found pitted and scratches were found on the edge of the device.Light guide was found squashed.Plastic around the biopsy opening was determined with scratches and burnt/melted.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.Based on evaluation findings, the reported issue was confirmed.The likely cause of the issue was attributed to maintenance and or mishandling.

Event Description

It was reported that a foreign object was blocking the device channel.The issue occurred during reprocessing.There was no patient involvement on this report.

Manufacturer Narrative

This supplemental report is being submitted to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Please see updated sections: g4, g7, h2, h3, and h10.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 10208349
• MDR Text Key: 222921792
• Report Number: 8010047-2020-03727
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

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: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 08/29/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1