MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-03-15 for OLYMPUS ENDOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[40349466]
The device referenced in this report was not returned to olympus for evaluation. The cause of the patient's outcome could not be determined. As part of our investigation, olympus made multiple follow ups to gather additional information regarding the event via telephone and in writing, but no additional information was obtained.
Patient Sequence No: 1, Text Type: N, H10
[40349467]
Olympus received a legal document on february 17, 2016 which alleges that following the admittance of a patient in (b)(6) 2014, the patient developed medical conditions after being examined by an unspecified endoscope. The medical conditions included: infection, renal insufficiency, respiratory insufficiency, sepsis, cardiac arrest, and dehydration. The patient sustained injuries as a result of a fall, and ultimately expired. The cause of death is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2016-00307 |
| MDR Report Key | 5500241 |
| Report Source | OTHER |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-14 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-02-16 |
| Date Added to Maude | 2016-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ENDOSCOPE |
| Generic Name | ENDOSCOPE |
| Product Code | GCM |
| Date Received | 2016-03-15 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | N/A |
| 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; 2. Other | 2016-03-15 |