MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,other report with the FDA on 2020-01-16 for SIF-Y0004 UNKNOWN manufactured by Olympus Medical Systems Corp..
[187259792]
The subject device was not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[187259793]
On november 21, 2019, olympus medical systems corp. (omsc) received a literature titled? Bile duct stone treatment using short-sbe (single balloon endoscope) for patients who experienced intestinal reconstructive surgery?. The literature reported the result of 151 cases of the bile duct stone treatment procedures using an olympus model sif-y0004 or sif-y0015 or sif-h290s between july 2013 and february 2019. On december 20, 2019, omsc obtained the information from the author of the literature that there is a possibility that the endoscopic perforation and the perforation during anastomotic expansion in the literature have a direct relationship with the olympus products. Therefore, omsc submits 3 mdrs for the perforation during anastomotic expansion in addition to 3 mdrs already submitted for the endoscopic perforation. This is 2 of 3 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-00914 |
| MDR Report Key | 9594767 |
| Report Source | LITERATURE,OTHER |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-01-16 |
| 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 | SIF-Y0004 |
| Generic Name | UNKNOWN |
| Product Code | FDA |
| Date Received | 2020-01-16 |
| Model Number | UNKNOWN |
| 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. Other | 2020-01-16 |