MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for HD AUTOCLAVABLE CAMERA HEAD CH-S190-XZ-E manufactured by Olympus Medical Systems Corp..
[72365293]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. Omsc tried to reproduce the phenomenon, but the phenomenon was not reproduced. Omcs will continue the evaluation the subject device and otv-s190 used in combination. The ch-s190-xz-e instruction manual states the corresponding method when there is an abnormality. 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
[72365294]
During the laparoscopic hysterectomy, this event occurred. Approximately 5 minutes to 10 minutes after the case was started, noise appeared on the endoscopic image, and the endoscopic image was not displayed. The user facility checked wiring and rebooted the subject device, but the phenomenon was not solved. The user facility replaced the subject device and otv-s190 with spare devices, and completed the procedure. After the procedure, the patient has no problem. Member of dealer who visited the user facility during this procedure, heard the abnormal noise from the connection portion between the subject device and otv-s190, before the endoscopic image disappeared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00398 |
| MDR Report Key | 6471081 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2015-08-20 |
| Date Added to Maude | 2017-04-07 |
| 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 KATSUAKI MORITA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| Manufacturer Phone | 8142642517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HD AUTOCLAVABLE CAMERA HEAD |
| Generic Name | AUTOCLAVABLE CAMERA HEAD |
| Product Code | KQM |
| Date Received | 2017-04-07 |
| Returned To Mfg | 2017-03-13 |
| Model Number | CH-S190-XZ-E |
| 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 CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-07 |