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 2018-06-07 for UNKNOWN SIF-Q260 manufactured by Olympus Medical Systems Corp..
[110333295]
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
[110333296]
On may 11, 2018, olympus medical systems corp (omsc) received a literature titled? Safety and efficacy of endoscopic bile duct stone treatment procedure for elderly people who experienced intestinal reconstructive surgery.? That was made in public in the 95th congress of the japan gastroenterological endoscopy society on may 2018. The literature reported the result of 186 cases (285 procedures) of endoscopic bile duct stones treatment using single balloon endoscopy (sbe) for the elderly people between january 2007 and september 2017. In the subject procedures, accidental symptoms reportedly occurred as follows; pancreatitis occurred in 9 procedures. Intestinal perforation occurred in 5 procedures. Cholangitis occurred in 5 procedures. Bleeding occurred in 3 procedures. Leakage pancreatic juice occurred in 1 procedure. -bile duct perforation occurred in 1 procedure. The literature concluded that, it was suggested that the procedure can be performed safety and effectively for even if the patient was elderly people (more than 75 years old) who experienced intestinal reconstructive surgery. Omsc reviewed the delivery history of the endoscopes (sbe type) and the history revealed that olympus small intestinal videoscopes (sif-y0004, sif-y0004-v01, sif-y0015, sif-h290s, sif-q260) had been delivered to the facility. Olympus is submitting mdr according to the number of procedural accidents case because it was not informed which endoscope model was used in the procedures. This is 5 of 24 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01043 |
| MDR Report Key | 7577254 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-07 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-06-07 |
| 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 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 | 2018-06-07 |
| Model Number | SIF-Q260 |
| 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 | 2018-06-07 |