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 2018-10-31 for EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE SIF-H290S manufactured by Olympus Medical Systems Corp..
[125593026]
The subject device has not been returned to omsc. Omsc reviewed the manufacturing history of the sif-h290s and confirmed no irregularity. The exact cause could not be determined. The instruction of the subject device already warns;? When using the endoscope, make appropriate judgments and treatments from trained specialist viewpoints to avoid complications such as bleeding, perforation, or pancreatitis. A medical literature reports that the incidence of complications such as gastrointestinal perforation is 5? 10% when using an endoscope for a patient with altered anatomy. If any complication is observed, immediately stop the endoscopy/treatment and take proper measures.?
Patient Sequence No: 1, Text Type: N, H10
[125593027]
Olympus medical systems corp. (omsc) was informed that during an endoscopic retrograde cholangiography (ercp) for a patient, who had experienced intestinal reconstructive surgery, the duodenum and the esophagus of the patient were perforated and the patient died several days after the ercp procedure. It was also reported that olympus sliding tube (st-sb1s) and sigmoid videoscope (sif-h290s) were used in the ercp procedure. Olympus followed up with the user facility to obtain additional information, but the user facility denied providing detailed further information on the event. In addition, there was no request from the user facility to olympus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02096 |
| MDR Report Key | 8022910 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2018-03-20 |
| Date Added to Maude | 2018-10-31 |
| 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 | EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE |
| Generic Name | SMALL INTESTINALVIDEOSCOPE |
| Product Code | FDA |
| Date Received | 2018-10-31 |
| Model Number | SIF-H290S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-10-31 |