MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2014-03-14 for HD AUTOCLAVABLE CAMERA HEAD CH-S190-XZ-E manufactured by Olympus Medical Systems Corporation.
[4414792]
Olympus medical systems corp (omsc) was informed that during a right upper lobe of lung resection, the subject device was released continuously without operating the release button of the subject camera head, and the images froze at every release. The phenomenon occurred when the procedure was at the step that the position near pulmonary artery was treated, and because of the freeze of the image, the pulmonary artery was injured. The hemostasis was performed immediately, and the procedure was completed with the subject device. There was no aftermath or delay of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[11855266]
The subject device was returned to olympus for inspection. A tape was winded around the cable near the camera head of the subject device and a leak was observed at the point. After the tape was peeled off, a damage of the cable's surface was observed. Another damage of it was observed at the different position, and a leak was also observed there. During the function test, the failure of its remote switch 1 was observed. After the disassembly of the camera head, the corrosion of the switch circuit board was observed. There was no irregularity of the subject device with the device history record. According to the observation of the leakage of water and the corrosion of the switch circuit board, the water soaked into inside of the camera head, remote switch circuit board corroded and the phenomenon occurred. This report is being submitted as a medical device report in an abundance of caution. .
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2014-00091 |
| MDR Report Key | 3757454 |
| Report Source | 01,07,08 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-02-17 |
| Date of Event | 2014-02-17 |
| Date Mfgr Received | 2014-02-17 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2014-06-13 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 26425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HD AUTOCLAVABLE CAMERA HEAD CH-S190-XZ-E |
| Generic Name | CAMERA HEAD |
| Product Code | KQM |
| Date Received | 2014-03-14 |
| Returned To Mfg | 2014-02-25 |
| Model Number | CH-S190-XZ-E |
| Catalog Number | CH-S190-XZ-E |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-14 |