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 2018-12-17 for FD-412LR (JA) manufactured by Olympus Medical Systems Corp..
[131708917]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. Omsc evaluated it on dec. 10, 2018, and found as follows; the foreign matter was adhered on the tip of the device. The resistance value between the tip of the device and the plug of the handle was normal. The device was successfully activated without problem. The manufacturing record was reviewed and found no irregularities. The exact cause of the reported event could not be conclusively determined because there were no defects on the subject device. However, based on the past similar cases, it was known that the event occurred due to any of the following possible causes. The conductivity decreased due to the burnt tissue adhered to the distal end of the device. 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 target tissue was immersed in fluid such as blood or mucous. The instruction manual of the device has already warned as follows; pulling the tissue when applying the current. This could cause patient injury such as perforations and/or bleeding. When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure. Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.
Patient Sequence No: 1, Text Type: N, H10
[131708918]
During an endoscopic hemostasis, the subject device was used. In the procedure, the device did not activate output. The intended procedure was completed with another device. There was no patient injury reported. This is the report regarding the failure of the output.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02447 |
| MDR Report Key | 8171838 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-11-28 |
| Device Manufacturer Date | 2018-07-19 |
| Date Added to Maude | 2018-12-17 |
| 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 | 2018-12-17 |
| Returned To Mfg | 2018-12-04 |
| Model Number | FD-412LR |
| Lot Number | 87K |
| 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 | 2018-12-17 |