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

Model Number CLV-S40PRO

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

Olympus field services investigated the subject device at user facility and followings were obtained.-the xenon lamp glass was broken.-the xenon lamp was not set appropriately.The subjected device was returned to olympus medical systems corp (omsc) for evaluation.Omsc is investigating the subject device.Clv-s40pro instruction manual states the corresponding method in case of an abnormality.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that the following information.During video assisted thoracic surgery, the breaking sound was occurred form the subject device.The endoscopic image became dark and the emergency lamp of the subject device was turned on.The user facility replaced the subject device with unspecified another system, and completed the procedure.There was no report of the patient¿s injury regarding this event.

Event Description

Olympus was informed the following information.An unspecified another system that the user used after the replacement was the visera pro system.

Manufacturer Narrative

The lamp in the subject clv-s40pro was returned to the manufacturer for the detailed investigation.The manufacturer reported the following investigation result to omsc.The glass of the lamp broke under the abnormal use.The stress was applied to the outer circumstance of the lamp because the lamp was attached to the heat sink diagonally.Consequently, the lamp was difficult to cool.It was surmised that the glass broke because the part under the stress was unable to withstand the thermal expansion.Based on these investigations, omsc surmised this event occurred by the following.The user did not attach the lamp to the heat sink properly.Therefore the reported result from the manufacturer occurred.There were no further details provided.If significant additional information is found, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: VISERA PRO XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6517640
• MDR Text Key: 73735967
• Report Number: 8010047-2017-00486
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2007
• 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