MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA XENON LIGHT SOURCE

Model Number CLV-S40

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During a nephrectomy, the subject device was used.The user selected standby mode of the subject device and put the light guide cable which was connected to the device on the surgical drape for about an hour and a half.After that, the surgical drape scorched.The brightness control of the device had been set to "manual".The intended procedure was completed with the subject device.There were no patient and facility staff injury reported.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc investigated the subject device and found there were no abnormalities on the subject device and it was within the specifications.The manufacturing record was reviewed and found no irregularities.Therefore, the exact cause of the reported event could not be conclusively determined.Based on the past similar cases, it was known that the surgical drape scorched since the user put the subject device on the surgical drape immediately after use or before the light guide cable was cooled.The instruction manual states the proper handling method of the subject device and the corresponding method in case of an abnormality.

• Brand Name: VISERA XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8730732
• MDR Text Key: 149388384
• Report Number: 8010047-2019-02286
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

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: CLV-S40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1