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 2017-12-18 for UNKNOWN manufactured by Unknown.
[95230496]
The subject device has not been returned to omsc for evaluation. Because the model name and serial number of this device are unknown, omsc couldn? T confirm the manufacturing history of this device. Also, the user facility has not complained of a malfunction with this device. Furthermore, olympus staff visited the user facility and confirmed the operation of the automated endoscope reprocessor, no irregularity was found. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[95230497]
Olympus medical systems corp. (omsc) was informed that two unknown procedures using the subject device were performed on two patients and the intended procedure was completed without problems. But, at a later date, two patients complained of abdominal pain, and they visited another hospital. The patients outcome are unknown. This device had been reprocessed using an olympus automated endoscope reprocessor model oer-3 (not available in the usa) with peracetic acid after manual cleaning. This is 2 of 2 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-02007 |
| MDR Report Key | 7124817 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-18 |
| Date Mfgr Received | 2017-11-27 |
| Date Added to Maude | 2017-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KATSUAKI MORITA |
| 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 | 0 |
| Brand Name | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | NWB |
| Date Received | 2017-12-18 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-18 |