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 2018-05-11 for SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS FD-410LR manufactured by Olympus Medical Systems Corp..
[108435735]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The subject device was tested for activation. It successfully activated without problem. 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: p-plate was not enough attached to the patient. The user felt that the subject device could not output due to the current density decreased due to increasing of contact area between the tissue and the subject device. The subject device was not connected to a cord or the power supply correctly. The instruction manual of the subject device has described inspecting method of connection for a code and electrosurgical unit. The instruction manual of the subject 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
[108435736]
During an endoscopic submucosal dissection of the stomach, the subject device was used. In the procedure, only the soft coagulation mode could not be activated. The user exchanged it with the second device (fd-412lr). It could not be activated. The intended procedure was completed. There was no patient injury reported. No further information was provided. This is the report regarding failure of activation for the first device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00814 |
| MDR Report Key | 7505707 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2018-04-18 |
| Device Manufacturer Date | 2018-02-09 |
| Date Added to Maude | 2018-05-11 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2018-05-11 |
| Returned To Mfg | 2018-04-26 |
| Model Number | FD-410LR |
| Lot Number | 82K |
| 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 | 2018-05-11 |