MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-09 for OLYMPUS VISERA PRO XENON LIGHT SOURCE CLV-S40PRO manufactured by Olympus Medical Systems Cooperation.
[37780627]
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.
Patient Sequence No: 1, Text Type: N, H10
[37780628]
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.
Patient Sequence No: 1, Text Type: D, B5
[40978720]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2016-00156 |
| MDR Report Key | 5418888 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-09 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-01-12 |
| Date Mfgr Received | 2016-02-26 |
| Device Manufacturer Date | 2007-09-24 |
| Date Added to Maude | 2016-02-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 42 6425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS VISERA PRO XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-02-09 |
| Returned To Mfg | 2016-01-25 |
| Model Number | CLV-S40PRO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS COOPERATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-09 |