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 2019-01-31 for SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS FD-410LR manufactured by Olympus Medical Systems Corp..
[134562814]
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. 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 target area was immersed in blood. The target area was immersed in water. 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
[134562815]
In the procedure, the doctor used two devices for hemostasis, but they did not activate output and could not stop bleeding. The doctor exchanged them for another firm's forceps. However, another firm's device did not activate output. The doctor exchanged a cautery instrument for another instrument. However, another cautery instrument did not work well. The doctor stopped bleeding by making a local injection of hypertonic saline epinephrine. There was no patient injury reported. This is the first one of two reports. This is the report regarding the failure of stopping bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-00982 |
| MDR Report Key | 8291907 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-31 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-02-20 |
| Device Manufacturer Date | 2018-10-20 |
| Date Added to Maude | 2019-01-31 |
| 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 | 2019-01-31 |
| Returned To Mfg | 2019-01-18 |
| Model Number | FD-410LR |
| Lot Number | 8XK |
| 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 | 2019-01-31 |