MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-11-20 for FD-412LR (JA) manufactured by Olympus Medical Systems Corp..
[128201102]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The subject device worked. The manufacturing record was reviewed and found no irregularities. Based on the past similar cases, it was known that the event occurred due to any of the following possible causes. The contact condition between the patient and the patient plate was bad. The subject device was not connected to the cord or the cord was not connected to the power supply correctly. The current density decreased due to burnt tissue attached to the distal end. The target area was immersed in blood. The target area was immersed in water. The instruction manual of the device has described the method of connection of a code. The instruction manual of the device has already warned as follows; pulling the tissue when applying the current.
Patient Sequence No: 1, Text Type: N, H10
[128201103]
During an endoscopic sudmucosal dissection, the malfunction of the two devices was reported. In the procedure, the doctor used two devices for hemostasis, but they could not stop bleeding. The intended procedure was completed with third device. There was no patient injury reported. This is the report regarding the failure of stopping bleeding. This is the first one of two reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02237 |
| MDR Report Key | 8093305 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 2018-01-13 |
| Date Added to Maude | 2018-11-20 |
| 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 | FD-412LR (JA) |
| Generic Name | SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS |
| Product Code | KGE |
| Date Received | 2018-11-20 |
| Returned To Mfg | 2018-11-12 |
| Model Number | FD-412LR |
| Lot Number | 81K |
| Device Availability | R |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |