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

Model Number CLV-S40

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

Olympus checked the subject device and concomitant devices (the video processor otv-s7v and the camera head otv-s7h) at the user facility, and there was no abnormality in these devices.After that, the subject device was returned to olympus, and olympus confirmed the subject device worked properly.The user facility already sent the telescope and the light guide cable used in the procedure to smith & nephew.So olympus could not check the subject device connected with the telescope and the light guide cable.A tip of a telescope becomes hot during turning on the examination lamp of this device.The facility placed the tip of the telescope on the medical drapes while the subject device turned on, so the patient might get burned because the hot tip of the telescope touched the patient's skin via the medical drapes.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 cautions for a telescope and a light guide cable handling during turning on the examination lamp of this device.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.

Event Description

The user facility confirmed the patient got burned and some drapes melted when the tip of the telescope contacted them during ankle arthroscopy.The user facility completed the procedure with replacing the subject device to another device.The user facility used the telescope and the light guide cable made by smith & nephew respectively in the procedure.The user facility commented they sometimes cover the tip of telescope with a swab, but they were not unsure whether they cover the tip of telescope with a swab at that time.

• Brand Name: 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: 5455848
• MDR Text Key: 38853346
• Report Number: 8010047-2016-00284
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2006
• 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
• Patient Outcome(s): Other