MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for MAJ-1154 SCOPE CABLE CV-260 manufactured by Olympus Medical Systems Corp..
[107233111]
The subject maj-1154 has not been returned to omsc. The subject maj-1154 will not be returned from the user. 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
[107233112]
During an unspecified procedure, an abnormal sounds (cracking noise and spark sound) were heard, and the endoscopic image showed a multitude of the colors on the monitor. The user canceled the procedure. There was no report of the patient? S injury regarding this event. The olympus local service engineer discussed with the user and identified that the subject maj-1154 was attributed to the cause of the failure phenomenon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00784 |
| MDR Report Key | 7467444 |
| Date Received | 2018-04-26 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-04-26 |
| 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 KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAJ-1154 SCOPE CABLE CV-260 |
| Product Code | NWB |
| Date Received | 2018-04-26 |
| Model Number | MAJ-1154 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-26 |