MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,user facil report with the FDA on 2020-02-17 for EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GIF-Q260J manufactured by Olympus Medical Systems Corp..
[184288964]
The subject device was not returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[184288965]
Olympus medical systems corp. (omsc) received a literature titled? Neurological symptoms and spinal cord embolism caused by endoscopic injection sclerotherapy for esophageal varices?. The following is a summary of the literature: the patient who had (b)(6) had the ligation treatment of esophageal and gastric varices with tissue glue injection under intravenous anesthesia. Olympus single use injector model nm-400l-0423 and gastrointestinal videoscope model gif-q260j were used for the procedures. The procedure was completed and the patient returned to the hospital ward. Six hours after the procedure, the patient complained of the weakness and numbness in the lower limbs, abdominal distension and slight dysuresia. The patient's vital signs were stable, lower extremities were normal, the right limb muscle strength was iv level, and bilateral babinski signs were positive. The patient had magnetic resonance imaging (mri) of the thoracic and lumbar spine within twelve hours postoperation and spinal cord embolism was detected. Therefore, the facility stopped the hemostatic and coagulation regimen immediately and started nerve nourishment and microcirculation therapies, along with dexamethasone injections. Three months after this treatment, cervical and thoracic mri did not show any embolism in the spinal cord. The user states in the literature that spinal cord embolism is rare complication of endoscopic injection sclerotherapy. Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined. Therefore, omsc will submit 2 medical device reports depending on the number of device. This report is a report of gif-q260j.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01362 |
| MDR Report Key | 9716154 |
| Report Source | FOREIGN,LITERATURE,USER FACIL |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-17 |
| 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 | EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE |
| Generic Name | GASTROINTESTINAL VIDEOSCOPE |
| Product Code | FDS |
| Date Received | 2020-02-17 |
| Model Number | GIF-Q260J |
| Device Availability | * |
| 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 | 2020-02-17 |