MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-18 for EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SIF-Q180 manufactured by Olympus Medical Systems Corp..
[183972855]
The article did not specify the serial number of the referenced scope; therefore, it is unknown if the scope was returned for repair/service. An instrument history is unable to be performed. Furthermore, the study's physician provided a probable cause of the reported death stating that "it was hypothesized that the patient's death may have been due to air embolism, although a pulmonary embolism, mucus plug, arrhythmia, and myocardial infarction are also possibilities. Prolonged manipulation and endoscopy time may result in more leakage of air through a newly formed gastrostomy into the peritoneum. However, the jejunal extension insertion using a single-balloon enteroscope is actually faster than the standard technique because of the lack of retrograde migration, and thus it was felt that this did not contribute to the adverse outcome in this patient. "
Patient Sequence No: 1, Text Type: N, H10
[183972856]
Olympus received an article titled? Insertion of percutaneous endoscopic gastrostomy tubes with jejunal extensions using the? Wedge? Technique: a novel method to prevent retrograde tube migration into the stomach?. There were 17 patients on the study. The article reported that two adverse events occurred due to peg insertion although none were related to the jejunal extension insertion itself using the wedge technique. One female patient developed asymptomatic pneumoperitoneum after the procedure. She was discharged 6 hours later when a repeat abdominal x-ray showed resolution of most of the free air. She remained asymptomatic until noon the following day when she took a nap with her husband, coughed once, and stopped breathing. Resuscitation was not performed, following the patient? S prior wishes. An autopsy was offered but declined. This is patient 2 of 2 adverse events for the subject study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01816 |
| MDR Report Key | 9849898 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-18 |
| 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 EXERA II SMALL INTESTINAL VIDEOSCOPE |
| Generic Name | SMALL INTESTINAL VIDEOSCOPE |
| Product Code | FDA |
| Date Received | 2020-03-18 |
| Model Number | SIF-Q180 |
| Operator | HEALTH PROFESSIONAL |
| 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. Death | 2020-03-18 |