MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-10-08 for OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V BML-V242QR-30 manufactured by Olympus Medical Systems Corporation.
[4962502]
Olympus medical system corp. (omsc) was informed that during crushing biliary stone, the basket caught the stone regularly but the metal sheath near handle buckled and the metal pipe broke abruptly. The doctor abandoned the procedure and performed open surgery to remove the basket from the patient. The patient was discharged after standard postoperative observation period. According to a report, the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[12213945]
The subject devices have not been returned to omsc for investigation. The exact cause of the user's experience could not be conclusively determined. A supplemental report will be submitted, if additional and significant information becomes available at a later time. 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 | 8010047-2014-00552 |
| MDR Report Key | 4196350 |
| Report Source | 99 |
| Date Received | 2014-10-08 |
| Date of Report | 2014-09-09 |
| Date of Event | 2014-07-15 |
| Date Mfgr Received | 2014-09-09 |
| Device Manufacturer Date | 2014-02-02 |
| Date Added to Maude | 2014-10-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V |
| Generic Name | MECHANICAL LITHOTRIPTOR |
| Product Code | FEO |
| Date Received | 2014-10-08 |
| Model Number | BML-V242QR-30 |
| Lot Number | 42K |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-08 |