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

Model Number CLV-S40

Device Problem Off-Label Use (1494)

Patient Problem Burn, Thermal (2530)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The following event was reported in the pharmaceuticals and medical devices agency (pmda) website (url:http://www.Pmda.Go.Jp/safety/info-services/medical-safety-info/0172.Html).After the user performed the inguinal hernia surgery, the user removed edema content fluid by scrotopuncture.At that time, to confirm the location of the blood vessel in the scrotum the user connected only a light guide cable to the subject device.And the user lit up the patient's scrotum by the light guide cable.The patient got burned.The above was mentioned on the document of the web site of the pmda.(the document of the web site of the pmda: the 3rd time medical supplies, medical device and regenerative medicine are a product safe use measure consideration report of the results.The case which could think the measure of a device by a manufacturing dealer was difficult (human error and human factor).The above report does not mention that treatment of the burn was continued and failures of the subject device have occurred.Investigation result by the pmda is mentioned on the document of the web site that there is a possibility of the mistake in user's judgment.

• Brand Name: VISERA XENON LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-sh, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-sh, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5606924
• MDR Text Key: 43597073
• Report Number: 8010047-2016-00583
• 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: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-S40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other