MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-29 for VISERA PRO XENON LIGHT SOURCE CLV-S40PRO manufactured by Olympus Medical Systems Corp..
[94282317]
The subject clv-s40pro was returned to omsc. However, omsc could not conduct the verification to reproduce the phenomenon with non-olympus lamp mounted in the subject clv-s40pro, because non-olympus lamp was not returned. Omsc mounted olympus lamp in the subject clv-s40pro, and confirmed the operation. Then the subject clv-s40pro was operated normally. As a result of the investigation, omsc concluded that there was no abnormality with the subject clv-s40pro and that this event was caused by using the non-olympus lamp. The clv-s40pro instruction manual states that never install a lamp that has not been approved by olympus. There were no further details provided. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[94282318]
The followings were reported to olympus medical systems corp. (omsc). -after 30 minutes from starting an abdominal laparoscopic salpingo resection, the lamp in the subject clv-s40pro was broken. -the user replaced the endoscopic system including the subject clv-s40pro with the spare system, and completed the procedure. -there was no report of the patient? S injure regarding this event. -the broken lamp was not olympus manufactured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01874 |
| MDR Report Key | 7066188 |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-11-08 |
| Date Mfgr Received | 2017-11-10 |
| Device Manufacturer Date | 2009-03-16 |
| Date Added to Maude | 2017-11-29 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KATSUAKI MORITA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VISERA PRO XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | NWB |
| Date Received | 2017-11-29 |
| Returned To Mfg | 2017-11-20 |
| Model Number | CLV-S40PRO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-29 |