MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-07-17 for AUTOCLAVABLE TRANSDUCER "MAJ-1215", FOR LUS-2 manufactured by Olympus Medical System Corporation.
[6008583]
Olympus was informed that during an unspecified procedure pieces of metal from the probe attachment broke off and fell into the patient. The device fragments were removed from the patient with a grasper and irrigation. An x-ray was performed to confirm all debris was removed. There was a short delay in the procedure and no patient bleeding was reported. The physician attempted to attach two different probes to the same hand-piece and neither probe would securely attach to the device which caused the suction not to work. There was no patient injury reported. Olympus followed up with user facility to obtain additional information regarding the reported event and was informed that the device was inspected prior to the procedure and no anomalies were found.
Patient Sequence No: 1, Text Type: D, B5
[13513843]
The referenced device in this report was returned to olympus for evaluation. The evaluation confirmed that the probe attachment was broken. The device was determined to be unserviceable and was discarded. This type of damage is most likely related to the operator's technique the instruction manual warns users "when connecting the hand pieces, do not apply excessive force to the hand piece cord. Doing so may cause equipment damage. If the ultrasonic output error indicator lights and all of the ultrasonic output level indicators, all of the suction level indicators, the output indication lamp and the suction indication lamp blinks, this means that lus-2 is not working properly; stable output cannot be supplied. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2015-00311 |
| MDR Report Key | 4921728 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-18 |
| Date Mfgr Received | 2015-06-26 |
| Device Manufacturer Date | 2007-05-09 |
| Date Added to Maude | 2015-07-17 |
| 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 | MRS. NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOCLAVABLE TRANSDUCER "MAJ-1215", FOR LUS-2 |
| Generic Name | AUTOCLAVABLE TRANSDUCER FOR LUS-2 |
| Product Code | FEO |
| Date Received | 2015-07-17 |
| Returned To Mfg | 2015-06-26 |
| Model Number | MAJ-1215 |
| Catalog Number | MAJ-1215 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO, HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-17 |