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

Model Number CLV-S40PRO

Device Problem Inadequate Lighting (2957)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.Olympus checked the subject device but there was no abnormality of the subject device.Olympus also evaluated the subject device with the concomitant devices (the otv-s7pro and the wa03201a), a spare camera head and a spare telescope.The amount of light emitted from the spare telescope was enough to perform a procedure.Olympus is continuing the investigation because the cause of this phenomenon is not determined yet.Olympus also checked the device history record of the subject device, and there was no irregularity found.There were no further details provided at this time.Olympus will submit a supplemental report when the result of this evaluation is found.Please cross reference the associated complaint files: mfr report#: 8010047-2016-00157.

Event Description

The facility inserted telescope to the patient through a trocar during the laparoscopy-assisted distal gastrectomy using the subject device and the otv-s7pro.At that time, the facility could not perform the procedure because a monitor image was dark.The facility replaced the light guide cable (wa03210a), the camera head and the telescope to another one respectively, but a monitor image was still dark.The facility aborted the laparoscopic procedure and performed an open surgery.The patient was hospitalized and there was no report of patient's condition after this event.The facility continued to use the camera heads and the telescopes which used in the procedure after the event occurred, and there was no report of abnormality for the camera heads and the telescopes.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2016-00156 to provide device evaluation results.Olympus confirmed the brightness of an image was dark with using the subject device and the concomitant devices (the otv-s7pro and the two light guide cables ((b)(4))).The intensity of the examination lamp of the subject device decreased to lower limit in that of standard value.It had already passed over 2 years since the subject device was manufactured, so the examination lamp of the subject device might deteriorate due to aging.Moreover, the optical fibers of the two returned light guide cables broke partly, resulting in less light emission from the returned light guide cables.From the above investigation, the maximum light intensity emitted from the telescope might decrease due to complicated factors which were the deterioration of the examination lamp of the subject device and damage in part of the light guide cables.Therefore, the light from the tip of telescope could not emit enough when the user facility observed patient's large abdominal cavity.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 following cautions.The cables should not be sharply bent, pulled, twisted or crushed.Cable damage can result.Replace the examination lamp with a new one if the examination lamp is old.There were no further details provided at this time.If significant additional information is received, this report will be supplemented.Please cross reference the associated complaint files: mfr report#: 8010047-2016-00157.

• Brand Name: OLYMPUS VISERA PRO 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: 5418888
• MDR Text Key: 37780627
• Report Number: 8010047-2016-00156
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2007
• 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