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 2018-09-19 for SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS FD-410LR manufactured by Olympus Medical Systems Corp..
[120731809]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The foreign material stuck to the distal end of the subject device. The resistance between the forceps cups and the plug of the handle was high. After removing the foreign material, there was no abnormality of the resistance between the forceps cup and the plug of the handle. The subject device worked. There were no defects on the subject device. 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 tissue stuck to the tip of the subject device lowered the conductivity. 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 increasing of contact area between the tissue and the subject device. 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
[120731810]
During an endoscopic submucosal dissection, the subject device was used. In the procedure, the doctor used the subject device for hemostasis, but the subject device did not activate output. The intended procedure was completed with another device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01799 |
| MDR Report Key | 7889270 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-09-19 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2018-06-04 |
| Date Added to Maude | 2018-09-19 |
| 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 | 2018-09-19 |
| Returned To Mfg | 2018-09-04 |
| Model Number | FD-410LR |
| Lot Number | 86K |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-09-19 |