MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for AUTOCLAVABLE TRANSDUCER FOR LUS-2 MAJ-1215 manufactured by Olympus Medical Systems Corp..
[78369609]
The referenced maj-1215 has been returned to olympus medical systems corp. (omsc) for evaluation, however the evaluation is in progress at this time. The exact cause of the reported event could not be conclusively determined at this time. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[78369610]
Olympus was informed that before the pcnl procedure, the facility could not perform the procedure because the ultrasonic output error indicator of lus-2 lit up and the ultrasonic output was not activated. The patient was already anesthetized. The facility changed the devices to the other similar device (non-olympus) and the procedure was completed. Olympus (b)(4) checked the devices and decided that this phenomenon was likely to be caused by the maj-1215 used with the lus-2. On may 25 2017, olympus was informed that the facility changed the devices to the other similar devices and the procedure was completed. There was no report of the patient? S injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00768 |
| MDR Report Key | 6662615 |
| Date Received | 2017-06-22 |
| Date of Report | 2017-07-14 |
| Date of Event | 2016-10-05 |
| Date Mfgr Received | 2017-06-27 |
| Date Added to Maude | 2017-06-22 |
| 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 | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AUTOCLAVABLE TRANSDUCER FOR LUS-2 |
| Generic Name | TRANSDUCER |
| Product Code | FEO |
| Date Received | 2017-06-22 |
| Model Number | MAJ-1215 |
| ID Number | 04953170157134 |
| Device Availability | N |
| 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 | 2017-06-22 |