MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-20 for OLYMPUS SINGL USE MECHANICAL LITHOTRIPTOR V BML--442QR-30 BML-V442QR-30 manufactured by Olympus America, Inc..
[4574351]
Olympus was informed that during a biliary tract procedure, the user attempted to retrieve a non-olympus balloon inside the patient; however, the device failed to retrieve the balloon. The patient was reported to have undergone an open surgery to resolve the issue.
Patient Sequence No: 1, Text Type: D, B5
[12156890]
The device referenced in this report has not been returned to olympus for evaluation. The exact cause of the user's experience could not be conclusively determined at this time. However, based on the information provided, the reported phenomenon appears to be due to user error, as the device was used off-label. The bml-v442qr instruction manual intended use section states: "this instrument has been designed to be used with an olympus endoscope for crushing calculi inside the bile duct. Do not use this instrument for any purpose other than its intended use". If additional information or if the device is received at a later time this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00239 |
| MDR Report Key | 3934877 |
| Report Source | 06 |
| Date Received | 2014-06-20 |
| Date of Report | 2014-06-02 |
| Date of Event | 2014-05-28 |
| Date Mfgr Received | 2014-06-02 |
| Date Added to Maude | 2014-07-16 |
| 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 | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 951311700 |
| Manufacturer Country | US |
| Manufacturer Postal | 951311700 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO, HACHIOJI-SHI |
| Manufacturer City | TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS SINGL USE MECHANICAL LITHOTRIPTOR V |
| Generic Name | MECHANICAL LILTHOTRIPTOR |
| Product Code | FEO |
| Date Received | 2014-06-20 |
| Model Number | BML--442QR-30 |
| Catalog Number | BML-V442QR-30 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | 2591 ISHIKAWA-CHO, HACHIOJI0-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-20 |