MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-02 for LITHOTRIPTOR V BML-V442QR-30 manufactured by Olympus.
[6536567]
During ercp lithocrush v device was inserted to break up gall stone. After attaching to gall stone and crushing it, the device disengaged from insertion portion and traveled to bile duct. Device was able to be retrieved after an add'l 20 minutes. Outcome: add'l time under general anesthesia, no harm or complications noted at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043891 |
| MDR Report Key | 4905572 |
| Date Received | 2015-07-02 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-07-01 |
| Date Added to Maude | 2015-07-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOTRIPTOR V |
| Generic Name | LITHOCRUSH |
| Product Code | FEO |
| Date Received | 2015-07-02 |
| Model Number | BML-V442QR-30 |
| Catalog Number | BML-V442QR-30 |
| Lot Number | 4XK |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | ANCHORAGE AK 99508 US 99508 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-02 |