MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-18 for SINGLE USE RETRIEVAL BASKET V FG-V422PR manufactured by Olympus Medical Systems Corp..
[130986192]
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
[130986193]
During a procedure of bile duct stone removal, the subject device was used. In the procedure, the user tried to retrieve the calculus with the subject device, but it could not be removed from the common bile duct because the calculus was large. When the user used an emergency lithotriptor, the wire of the subject device broke. The user performed surgery to remove the subject device and the calculus. No further information was provided. This is the report regarding the additional procedure due to breakage of the wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02457 |
| MDR Report Key | 8177192 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-12-03 |
| Date Added to Maude | 2018-12-18 |
| 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 BASKET V |
| Generic Name | SINGLE USE RETRIEVAL BASKET |
| Product Code | OCZ |
| Date Received | 2018-12-18 |
| Returned To Mfg | 2019-02-18 |
| Model Number | FG-V422PR |
| 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 CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-18 |