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 2014-07-02 for HD AUTOCLAVABLE CAMERA HEAD CH-S190-XZ-E manufactured by Olympus Medical Systems Corporation.
[4689907]
Olympus was informed that during the endoscopic removal of the cerebral hematoma, the facility had connected the ch-s190-xz-e to the video processor otv-s190, the error b30 (indicating the otv-s190 could not communicate with the ch-s190-xz-e) had been displayed on the monitor. The facility had detached the ch-s190-xz-e from the otv-s190 and wiped the surface of the connector of the ch-s190-xz-e. Then the facility had reconnected the ch-s190-xz-e to the otv-s190, however the error b30 had been displayed on the monitor again. The facility had completed the procedure with use of the other ch-s190-xz-e. There was no report of the patient's injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
[11945135]
The referenced ch-s190-xz-e was returned to the olympus medical systems corporation (omsc) for evaluation. The evaluation confirmed the user's report, however could not identify the cause of this phenomenon. There was no abnormality and/or irregularity of the exterior of the device. Also, omsc checked the manufacture history of the subject ch-s190-xz-e, there was no irregularity found. Omsc stated the appropriate handling of the ch-s190-xz-e in the instruction manual when the ch-s190-xz-e had abnormalities. If significant additional information is received, this report will be supplemented. 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 | 8010047-2014-00343 |
| MDR Report Key | 4007918 |
| Report Source | 01,07,08 |
| Date Received | 2014-07-02 |
| Date of Report | 2014-06-03 |
| Date of Event | 2014-06-03 |
| Date Mfgr Received | 2014-06-03 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2014-08-25 |
| 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 | 0 |
| 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 |
| Generic Name | CAMERA HEAD |
| Product Code | KQM |
| Date Received | 2014-07-02 |
| Returned To Mfg | 2014-06-11 |
| 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 | 2014-07-02 |