MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-26 for UNKNOWN manufactured by Unknown.
[186687454]
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
[186687455]
Olympus medical systems corp. (omsc) received a literature title therapeutic peroral direct cholangioscopy using a single balloon enteroscope in patients with roux-en-y anastomosis (with videos). The literature reported the result of 169 cases of the peroral direct cholangioscopy (pdcs) using single-balloon enteroscope (sbe) procedures using an olympus model small intestinal video scope, sif-h290s and sif-y0015 between november, 2012 and november, 2016. In the subject procedures, 1 case of pancreatitis reportedly occurred. Based on the available information, a direct relationship between the subject devices and the observed reported adverse event could not be determined. According to the number of the accidental symptoms known and the number of olympus devices used for procedure, omsc is submitting 2 medical device reports. This is 2nd of 2 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01868 |
| MDR Report Key | 9881984 |
| Report Source | LITERATURE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-26 |
| 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 VIDEO SCOPE |
| Product Code | FDA |
| Date Received | 2020-03-26 |
| Model Number | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |