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

Model Number GIF-H190

Device Problems Partial Blockage (1065); Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation of the device found with foreign material inside the forceps passage, broken brush in instrument channel was found.The distal end (plastic cover) were observed with deep dents and scratches.In addition, a cracked objective lens were observed.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 root cause likely attributed to user¿s maintenance and handling issue.

Event Description

It was reported that the cleaning brush became stuck in the instrument channel.User was advised to soak the scope to maybe dislodge the cleaning brush.Scope was soaked in highly disinfecting solution.The issue was not resolved.The reported event occurred during device reprocessing.There was no patient involvement on this report.

Manufacturer Narrative

This report is being supplemented to provide additional information based on legal manufacturer's final investigation.Based on the device inspection results, this supplemental report is 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.The investigation determined that causes for the malfunction are not potential adverse events.The user "suggested event" was "cleaning brush became stuck during reprocessing".There was no information to confirm insufficient / incorrect reprocessing.

• 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: 10652502
• MDR Text Key: 223662634
• Report Number: 8010047-2020-07427
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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: 09/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1