MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-09 for SINGLE USE MECHANICAL LITHOTRIPTOR V BML-V237QR-30 manufactured by Olympus Medical Systems Corp..
[178339471]
The subject device referenced in this report was not returned to olympus for evaluation. Therefore the exact cause of the reported event could not be conclusively determined at this time. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10
[178339472]
We received the following report. *during an endoscopic retrograde cholangiopancreatography, the subject device was used. The user tried to crush the calculus. However, the user could not crush the calculus. The user tried to crush the calculus with the emergency lithotriptor. The operating wire of the subject device was broken off. The user performed an open surgery and removed the subject device together with the calculus from the patient body. The model number of the subject device was not provided. This is the report regarding the switching to the open surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-00849 |
| MDR Report Key | 9568210 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-09 |
| Date of Report | 2020-04-03 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-01-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE MECHANICAL LITHOTRIPTOR V |
| Generic Name | SINGLE USE MECHANICAL LITHOTRIPTOR |
| Product Code | LQC |
| Date Received | 2020-01-09 |
| Model Number | BML-V237QR-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-09 |