MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-08-07 for OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V BML-V242QR-30 manufactured by Olympus Medical Systems Corporation.
[15953294]
The coil sheath was returned to omsc for investigation. However, we couldn't confirm the basket wire since it was not returned. The investigation confirmed that there were multiple deformations on the coil sheath. According to the investigation, omsc considers that the calculus was too hard to crush and it caused this event. The device instruction manual has warned users that there is possibility the calculus cannot be crushed by lithotriptor, and it is 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
[15998056]
Olympus medical system corp. (omsc) was informed that during crushing calculus with the lithotripter in the common bile duct, the doctor couldn't' crush it. He couldn't withdraw calculus and the device from the patient. The facility cut the insertion portion of the device and removed the sheath and used emergency handle. However, they apprehended perforation of the common bile duct and decided to perform open surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2014-00433 |
| MDR Report Key | 4006322 |
| Report Source | 01,08 |
| Date Received | 2014-08-07 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-05-26 |
| Date Mfgr Received | 2014-07-18 |
| Date Added to Maude | 2014-08-14 |
| 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 | 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 | 2014-08-07 |
| Returned To Mfg | 2014-07-18 |
| Model Number | BML-V242QR-30 |
| Catalog Number | BML-V242QR-30 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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, TOYKO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-07 |