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

Model Number CLV-S40

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/13/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device and concomitantly-used video processor and camera head were returned to the olympus for evaluation.Olympus checked the subject device with the other returned devices connected and confirmed all devices worked properly.Olympus could not determine which devices were contributed to the reported phenomenon because the phenomenon was not reproduced.The related devices were not found any abnormalities, so there was a possibility that the phenomenon was attributed to the user handling of the devices.The instruction manual of clv-s40 already mentions the appropriate device handling when clv-s40 has abnormalities.Olympus also checked the device history record of the subject device and there was no irregularity found.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.Please cross reference the associated complaint files: mfr report #: 8010047-2015-00142 and 8010047-2016-00043.

Event Description

Olympus medical systems corporation (omsc) performed a mdr retrospective review and omsc found that this initial report is required on december 18, 2015.Olympus was informed that during the tur (transurethral resection) procedure the halation had occurred on the endoscopic image repeatedly.The facility replaced the otv-s7v connected to the subject device to another device to complete the procedure.There was no report of the patient's injury in this event.

• Brand Name: OLYMPUS VISERA 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: 5353405
• MDR Text Key: 35354629
• Report Number: 8010047-2016-00042
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• 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: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2005
• 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
• Treatment: OTV-S7V