MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE LTF-190-10-3D manufactured by Olympus Medical Systems Corp..
[91827704]
The subject device has not been returned to olympus medical systems corp(omsc). Omsc could not review the service and manufacturing record because the serial number were not provided from the facility. There was no malfunction report of the subject device concerning this case. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[91827705]
On october 12, 2017, olympus medical systems corp (omsc) received a literature titled? Study in treatment results after laparoscopic rectal resection using 3d endoscope system? That was made in public in (b)(6) digestive disease week in (b)(6) 2017. The literature reported the study result of 24 cases between august 2014 and december 2016 compared with the result before introducing the olympus 3d endoscope system to the facility. The literature reported that complications after the surgery using the 3d endoscope were wound infection (one case), anastomotic leakage (one case) and paralytic ileus (two cases). Complications of surgery using normal endoscope were wound infection (two cases) and anastomotic (six cases). In conclusion, the literature stated that the rectal resection using the 3d endoscope system possibly bring improvements in accuracy in the procedure less invasive results to the operator and the system is very useful device especially for young surgeons. Omsc review the sales history record for the facility and confirmed olympus ltf-s190-10 possibly used in the procedures. This is one of four reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01707 |
| MDR Report Key | 7016568 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-10 |
| Date Mfgr Received | 2017-10-12 |
| Date Added to Maude | 2017-11-09 |
| 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 KATSUAKI MORITA |
| 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 | 0 |
| Brand Name | ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE |
| Generic Name | FLEX 3D DEFLECTABLE VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2017-11-09 |
| Model Number | LTF-190-10-3D |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2017-11-09 |