MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,user facility report with the FDA on 2018-11-30 for EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[128861567]
The subject device was not been 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.
Patient Sequence No: 1, Text Type: N, H10
[128861568]
Olympus medical systems corp. (omsc) received a literature titled? Study on bowel endoscopic ercp (be-ercp) using small intestinal scope in the bile duct stone for the elderly patients who experienced intestinal reconstructive surgery? That was made in public in 26th japan digestive disease week (jddw). The literature reported the result of the be-ercp procedures for bile duct stones in 189 cases for the elderly patients and the procedures were conducted between november 2008 and january 2018 at user facility. In the procedures, pancreatitis (1. 2%: over 75 years, 1. 9%: under 75 years), perforation (4. 7%: over 75 years, 3. 8%: under 75 years), bleeding (1. 2%: over 75 years, 1. 9%: under 75 years) and respiratory failure (0%: over 75 years, 1. 0%: under 75 years) as accidental symptom reportedly occurred. In the jddw, it was also reported that olympus small intestinal videoscope model sif-q260 or sif-h290s were used in the procedures. Omsc tried to obtain detailed information, but additional information was not obtained. Omsc is submitting mdr according to the number of types of the accidental symptom. This is 2 of 4 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02329 |
| MDR Report Key | 8118696 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-30 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2018-11-30 |
| 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 ELITE SMALL INTESTINALVIDEOSCOPE |
| Generic Name | SMALL INTESTINAL VIDEOSCOPE |
| Product Code | FDA |
| Date Received | 2018-11-30 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-30 |