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 2014-05-20 for OLYMPUS ULTRASONIC LITHOTRIPTOR PROBE MAJ-985 manufactured by Olympus Medical System Corporation.
[4542472]
Olympus was informed that at the beginning of lithotripsy procedure, when the foot pedal was pressed and after 10 minutes at output level 3, the probe broke in half and fell inside the patient. The device was retrieved without incident and the intended procedure was completed with another similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[12107136]
The device referenced in this report has not yet been returned to olympus for evaluation. The exact cause of the user's experience could not be conclusively determined at this time. If additional information becomes available at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00202 |
| MDR Report Key | 3896050 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-05-20 |
| Date of Report | 2014-05-06 |
| Date of Event | 2014-05-05 |
| Date Mfgr Received | 2014-05-06 |
| Date Added to Maude | 2014-07-09 |
| 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 | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO, HACHIOJI-SHI |
| Manufacturer City | TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ULTRASONIC LITHOTRIPTOR PROBE |
| Generic Name | LITHOTRIPTOR PROBE |
| Product Code | FEO |
| Date Received | 2014-05-20 |
| Model Number | MAJ-985 |
| Catalog Number | MAJ-985 |
| Lot Number | UNK |
| ID Number | NA |
| 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 SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO, HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-20 |