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..
[110337339]
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
[110337340]
On may 11, 2018, olympus received literature titled? A study of single-balloon endoscopic treatment for pancreatic biliary tract disease associated with patients having reconstructed gastrointestinal anatomy in our hospital.? That was made in public in japan digestive disease week (jddw). The literature reported the result of 27 cases of the endoscopic treatment using olympus single balloon enteroscope between april 2008 to october 2017. In the procedures, following accidental symptoms reportedly occurred. Pancreatitis: 4 cases, bile duct inflammation: 1 case, micro perforation: 3 cases, aspiration pneumonia: 1 case, three cases of perforation improved by conservative medical treatment. Olympus reviewed the delivery history of endoscopes for the facility and confirmed olympus sif-h290s, sif-y0004-v01, sif-y0015, and sif-q260 were delivered. Olympus is submitting mdr according to the number of accidental symptoms case because it was not informed that which endoscope model was used in the procedures. This report is 8 of 9 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01036 |
| MDR Report Key | 7576778 |
| 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 |