MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-07 for OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V BML-V232QR-30 manufactured by Olympus Medical Systems Corporation.
[15817174]
Olympus medical system corp (omsc) was informed that during crushing hard stone which size was about 2cm in the bile duct, the wire broke. The doctor attempted to crush it with emergency handle but it broke again. Then, the doctor tried to remove the broken wire from papilla by using a snare but he couldn't since the stone lodged in the pt body. He continued to push and pull the device and the stone came free from the wire. Finally, he could remove the subject product from the pt. Reportedly, the pt will receive open surgery to remove the stone.
Patient Sequence No: 1, Text Type: D, B5
[16130771]
The subject product was returned to omsc for investigation. The investigation confirmed that the basket wire was broken at the junction with the pipe. There were no abnormalities found upon investigation of the condition of the solder part and the outer diameter of the pipe. The basket was deformed and the coil sheath had slips. In addition, the basket wire also broke at about 1310 mm from the distal end of the basket and the broken portion was extended. As the checking of the manufacturing record of the same lot, nothing abnormal detected. Omsc considers that the condition of patient or calculus caused the failure of crushing calculus and the breakage. The device instruction manual has warned users that there is possibility the calculus cannot be crushed by lithotriptor, and it also describes what to do if the lithotriptor cannot crush the calculus. 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 | 8010047-2015-00027 |
| MDR Report Key | 4407130 |
| Report Source | 05,06 |
| Date Received | 2015-01-07 |
| Date of Report | 2014-12-09 |
| Date of Event | 2014-12-09 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-01-26 |
| 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, TOKYO 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 | 2015-01-07 |
| Returned To Mfg | 2014-12-16 |
| Model Number | BML-V232QR-30 |
| Lot Number | K4711 |
| Device Availability | Y |
| 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, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-07 |