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 2017-11-09 for EVIS GASTROINTESTINAL VIDEOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[91443224]
The subject device has 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
[91443225]
On (b)(6) 2017, olympus medical systems corp (omsc) received a literature titled? Treatment efficacy of short-type single-balloon endoscopy (s-sbe) using for patients who experienced intestinal reconstructive surgery in endoscopic retrograde cholangiography (ercp)? That was made in public in japan digestive disease week (jddw) on october 2017. The literature reported the result of 74 cases; 144 procedures (before s-sbe introduction: 119 procedures, after s-sbe introduction: 25 procedures) between january 2013 and february 2017. In the subject procedures, following complications reportedly occurred. - before s-sbe introduction: perforation occurred in 2 procedures, and pancreatitis occurred in 6 procedures. - after s-sbe introduction: perforation occurred in 0 procedure, pancreatitis occurred in 3 procedures. The literature concluded that, s-sbe was considered to be useful because it enables to perform a safe and wide-ranging treatment in ercp for patients who experienced intestinal reconstructive surgery. The presenter of the literature stated that olympus endoscope model sif-h290s, sif-q260, gif-xq260, gif-2t240 and gif-xq260j were used for the procedures (omsc reviewed the sales history record and confirmed that the facility did not purchased the gif-xq260j but gif-q260j). Olympus is submitting mdr according to the number of complication case because it was not informed which endoscope model was used in the procedures. This is 5 of 11 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01696 |
| MDR Report Key | 7012516 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2017-11-09 |
| Date of Report | 2019-03-03 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2017-11-09 |
| 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 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 | 3 |
| Brand Name | EVIS GASTROINTESTINAL VIDEOSCOPE |
| Generic Name | GASTROINTESTINAL VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2017-11-09 |
| 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 | 2017-11-09 |