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

Model Number CLV-S190

Device Problem No Display/Image (1183)

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

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

The subject clv-s190 was not returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject clv-s190 to identify the root cause of this failure phenomenon when omsc receives it. The exact cause of the reported event could not be conclusively determined at this time. The clv-s190 instruction manual states the corresponding method when there is an abnormality for the device. There were no further details provided. If significant additional information is received, this report will be supplemented.

Event Description

The user used the subject xenon light source clv-s190 and video system center otv-s190 in the laparoscopic surgery of gynecology. At the beginning of the procedure, the user inserted the endoscope into the patient¿s body. At that time, the color of the endoscopic image became abnormal and the endoscopic image became dark. The user replaced the subject clv-s190 and otv-s190 with the similar device and completed the procedure. There was no report of the patient's injury regarding this event.

Manufacturer Narrative

The subject clv-s190 was returned to olympus medical systems corp. (omsc) for evaluation. Omsc continued to investigation the referenced devices, however the phenomenon could not reproduced. Omsc determined that the subject clv-s190 met specifications. The exact cause of the reported event could not be conclusively determined, however there is possibility of this phenomenon is attributed to the following. The user handling of the device was inappropriate, such as the temporal ingress of liquid and/or foreign material into the subject clv-s190. It caused by the usage environment of the facility, such as the temporal malfunction due to the noise. Olympus stated the appropriate handling of clv-s190 and the counter measures against abnormalities in the instruction manual of clv-s190. There were no further details provided. If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

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

• Brand Name: VISERA ELITE XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8017559
• MDR Text Key: 125637568
• Report Number: 8010047-2018-02080
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No