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 2018-07-04 for SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS FD-411QR manufactured by Olympus Medical Systems Corp..
[113509083]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The forceps did not open and close since foreign material adhered to the distal end. After removed foreign material, we could open and close the forceps. 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 since foreign material adhered to the forceps. The instruction manual of the device has already warned as follows; *if you use the instrument several times during one procedure, confirm that there is no irregularity with its operation and appearance, each time you use it. *do not use the instrument if you detect any abnormality. The breakage of the distal end such as the operation wire detachment could cause mucous membrane damages.
Patient Sequence No: 1, Text Type: N, H10
[113509084]
During an endoscopic submucosal dissection, the subject device was used. In the procedure, the doctor used the subject device for hemostasis, the subject device could not grasp the tissue and could not stop bleeding after two hours of use. The intended procedure was completed with another device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01274 |
| MDR Report Key | 7662057 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-04 |
| Date of Report | 2018-07-04 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2018-07-04 |
| 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 | 2018-07-04 |
| Returned To Mfg | 2018-06-18 |
| Model Number | FD-411QR |
| Lot Number | 84K |
| 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 | 2018-07-04 |