MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-27 for OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V BML-V232QR-26 manufactured by Olympus Medical Systems Corporation.
[5547326]
Olympus medical system corp. (omsc) was informed that during endoscopic retrograde cholangio pancreatography (ercp), the operation pipe broke. The doctor withdrew the subject device from the patient and attempted to crush the stone with another bml-v232qr-26 but the coil sheath was deformed. He thought that the breakage of the device might occur again if he continued to perform the procedure and abandoned it. After 5 days, the doctor crushed 4 or 5 stones including about 3cm large size stone. The patient was recovering.
Patient Sequence No: 1, Text Type: D, B5
[12950919]
The subject 2 devices were returned to omsc for investigation. The device which was initially used was broken at the junction with the basket wire and the pipe. There were no abnormalities found upon investigation of the condition of the welded part. The basket was deformed. The basket of the second device was also deformed. In addition, there were slips on the coil sheath. As the checking of the manufacturing record of the same lot, nothing abnormal detected. According to the investigation and report from the user facility, omsc considers that the condition of patient or calculus caused the failure of crushing calculus and the breakage. 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 | 8010047-2015-00138 |
| MDR Report Key | 4568347 |
| Report Source | 05,06 |
| Date Received | 2015-02-27 |
| Date of Report | 2014-02-04 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-04 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-04-02 |
| 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 | HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 26425177 |
| Single Use | 0 |
| 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 | 2015-02-27 |
| Returned To Mfg | 2015-02-10 |
| Model Number | BML-V232QR-26 |
| Lot Number | K4618 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-02-27 |