MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-12 for EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[178737439]
The subject device in this report has not been returned to olympus medical systems corp. (omsc) for evaluation. Since the serial number of the subject device is unknown and omsc could not confirm the manufacturing history (dhr). The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[178737440]
Olympus italy (oit) became aware of an article in a journal about an unexpected death of a patient. According to the article, the patient was admitted to the user facility for pancreatitis in (b)(6) 2019. The patient underwent endoscopic retrograde cholangiopancreatography (ercp) using an unspecified duodenoscope on (b)(6) 2019, with good results. Later on, the patient underwent another endoscopy using an unspecified gastroscope and had a hematemesis. The patient died due to this fatal hematemesis. After the event, the hospital was ordered to perform an autopsy of the patient by italian deputy prosecutor. The article does not directly indicate that olympus products were used for procedures. However, it is most likely that these procedures were performed with olympus endoscopes since the user facility is only using olympus endoscopes. Oit contacted the user facility in order to get detailed information on the event. The head of endoscopy department at the user facility has excluded that there may be a correlation with the videoduodenoscope and the videogastroscope used in this event. The model number and serial number of the endoscopes used for the procedures are unknown. Oit asked the user facility to send the endoscopes back to oit, but the user facility has not responded yet. Omsc is submitting two medical device reports according to the number of the endoscopes that were most likely used for the patient. This is for the unspecified olympus gastroscope and two of two reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01307 |
| MDR Report Key | 9698633 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 EXERA III GASTROINTESTINAL VIDEOSCOPE |
| Generic Name | GASTROINTESTINAL VIDEOSCOPE |
| Product Code | FDS |
| Date Received | 2020-02-12 |
| 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. Death | 2020-02-12 |