MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION OLYMPUS VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device is not returned to olympus yet.Olympus will investigate the subject device to determine the cause of this phenomenon after olympus receives it.Olympus will submit a supplemental mdr report after the cause of this phenomenon is found.

Event Description

Olympus was informed that a monitor image became dark in about 30 minutes after the facility started the laparoscopic cholecystectomy.When the phenomenon occurred, the light was not emitted from the tip of the scope which the facility used in the procedure.The facility replaced the subject device to another device with a workstation to complete the procedure.There was no report of patient's injury in this event.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2015-01259 to provide device evaluation results.The subject device was returned to olympus for evaluation.Olympus confirmed the subject device worked properly.When olympus visited the user facility to check the phenomenon, olympus confirmed the power plug of the subject device was not connected to the transformer output socket of the mobile workstation firmly.The reported phenomenon was reproduced when olympus checked the subject device without connecting the power plug to the subject device firmly.The power supply for the subject device might be unstable due to unfirm power plug connection of the subject device to the transformer output socket, resulting in the this phenomenon.Olympus also checked the device history record of the subject device, and there was no irregularity found.The instruction manual of this device already mentions that an operator should be sure to connect the power plug securely to prevent unintentional disconnection during use.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: OLYMPUS VISERA ELITE XENON LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5325866
• MDR Text Key: 34303382
• Report Number: 8010047-2015-01259
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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