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 manufactured by Olympus Medical Systems Corp..
[110340427]
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 by 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
[110340428]
On may 11, 2018, olympus received literature titled? Current status and problems of treatment with a short single-balloon endoscope for pancreatic, biliary tract disease in patients having reconstructed gastrointestinal anatomy? That was made in public in japan digestive disease week (jddw). The literature reported the result of 123 cases of the endoscopic retrograde cholangiopancreatography using olympus single balloon enteroscope between august 2011 to october 2017. In the procedures, following complications reportedly occurred: mild pancreatitis: 3; bile duct inflammation: 4; perforation: 3; aspiration pneumonia: 1. Two cases of perforation required emergency surgery, but others improved by conservative treatment. Olympus reviewed the delivery history of endoscopes for the facility and confirmed sif-290s, sif-y0004, and sif-y0015 were delivered. 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 report is 7 of 11 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01029 |
| MDR Report Key | 7576776 |
| 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 | 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 | 2018-06-07 |
| Model Number | UNKNOWN |
| Lot 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 | 2018-06-07 |