MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,user facility report with the FDA on 2018-06-08 for UNKNOWN manufactured by Olympus Medical Systems Corp..
[110450299]
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
[110450300]
On may 11, 2018, olympus medical systems corp. (omsc) received a literature titled? Study on bile duct stone treatment using short-sbe (single balloon endoscope) for patients who experienced intestinal reconstructive surgery?. The literature reported the result of the 104 procedures of stone treatments which were conducted between july 2013 and october 2017 at the user facility. In the 104 procedures, olympus small intestinal videoscopes ( sif-y0004, sif-y0015, sif-h290s ) were used. The literature reported following 14 case of accidental symptoms occurred in the procedures. Pancreatitis in 7 cases. Cholangitis in 4 cases. Perforation in 3 cases. Omsc reviewed the complaint record on the user facility and confirmed that olympus already submit 12 medical reports on the 12 of 14 accidental symptoms as follows; 8010047-2017-01619, 8010047-2017-01597, 8010047-2017-01594, 8010047-2017-01598, 8010047-2017-01599, 8010047-2017-01600, 8010047-2017-01601, 8010047-2017-01602, 8010047-2017-01603, 8010047-2017-01604, 8010047-2017-01605, 8010047-2017-01606 since there was no information on the model of the small intestinal videoscopes that was used in the procedures, omsc is submitting mdrs according to the two additional accidental symptoms cases (pancreatitis in 1cases, perforation in 1 cases). This is two of two reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01096 |
| MDR Report Key | 7581056 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-06-08 |
| 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 | UNKNOWN |
| Generic Name | SMALL INTESTINAL VIDEOSCOPE |
| Product Code | FDA |
| Date Received | 2018-06-08 |
| Model Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-08 |