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 2018-10-22 for SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS FD-411QR manufactured by Olympus Medical Systems Corp..
[124547700]
The subject device referenced in this report has not yet been returned to olympus for evaluation. Therefore the exact cause of the reported event could not be conclusively determined at this time. 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
[124547701]
During a procedure, the subject device was used. In the procedure, the doctor used the subject device for hemostasis, but the subject device could not stop bleeding. The intended procedure was completed with another device. There was no patient injury reported. This is the report regarding the failure of stopping bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02039 |
| MDR Report Key | 7988701 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-10-22 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2018-07-18 |
| Date Added to Maude | 2018-10-22 |
| 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 ELECTROSURGICAL HEMOSTATIC FORCEPS |
| Generic Name | SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS |
| Product Code | KGE |
| Date Received | 2018-10-22 |
| Returned To Mfg | 2018-10-22 |
| Model Number | FD-411QR |
| Lot Number | 87K |
| 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 | 2018-10-22 |