MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-29 for SINGLE USE RETRIEVAL NITINOL BASKET V FG-V451P manufactured by Olympus Medical Systems Corp..
[146474261]
The subject device was not returned to olympus medical systems corp. (omsc). The exact cause has been under investigation. 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
[146474262]
During an endoscopic retrograde cholangiopancreatography, the subject device was used. When the user retrieved the calculus, the guide wire tip of the subject device was broken. The user removed the subject device from the bile duct and there was bleeding from the bile duct. No additional treatment was reported. The intended procedure was completed with the subject device. The user commented that the basket or the guide wire tip of the subject device might have injured patient's bile duct. This is the report regarding the bleeding from the bile duct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-02048 |
| MDR Report Key | 8652524 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-29 |
| Date of Report | 2019-08-07 |
| Date of Event | 2019-05-14 |
| Date Mfgr Received | 2019-07-26 |
| Date Added to Maude | 2019-05-29 |
| 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 RETRIEVAL NITINOL BASKET V |
| Generic Name | SINGLE USE RETRIEVAL BASKET |
| Product Code | LQR |
| Date Received | 2019-05-29 |
| Model Number | FG-V451P |
| 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 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 | 2019-05-29 |