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 2018-04-21 for SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS FD-410LR manufactured by Olympus Medical Systems Corp..
[106872170]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The subject device worked. There were no defects on the subject device. 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 contact state between the patient plate and the patient was bad. -the current density decreased due to increasing of contact area between the tissue and the subject device. -there was insufficient connection between the subject device and the cord or the code and the power supply. The instruction manual of the device has already warned as follows; insert the a cord jack into the plug and confirm that it clicks into place. Pulling the tissue when applying the current.
Patient Sequence No: 1, Text Type: N, H10
[106872531]
During a gastric endoscopic submucosal dissection, the user tried to stop bleeding with the subject device. However, the subject device was not activated. The intended procedure was completed with another device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00689 |
| MDR Report Key | 7449403 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-04-21 |
| Date of Report | 2018-04-21 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-04-05 |
| Device Manufacturer Date | 2017-12-29 |
| Date Added to Maude | 2018-04-21 |
| 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 | 2018-04-21 |
| Returned To Mfg | 2018-04-10 |
| Model Number | FD-410LR |
| Lot Number | 7ZK |
| 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 | 2018-04-21 |