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 2018-12-27 for UNKNOWN manufactured by Olympus Medical Systems Corp..
[131620686]
The subject devices have not been returned to omsc for evaluation. There was no malfunction report of the subject device associated to the reported patient outcomes. Since the serial numbers of these devices were not informed, omsc could not confirm the manufacturing history. The exact cause of the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[131620687]
On november 29, 2018, olympus medical systems corp. (omsc) received a literature titled? A study of procedure related endoscopic retrograde cholangiopancreatography (ercp) for postgastrectomy cases (roux-en-y reconstruction, billroth ii)?. The literature reported the study result on 90 cases of ercp procedures between november 2011 and july 2018 at the user facility for postgastrectomy cases having duodenal papilla. The literature reported that olympus endoscopes (pcf-q260ai, gif-q260, sif-h290s, pcf-pq260l, gif-q260j, pcf-q260azi, sif-q260, gif-2tq260m or jf-260v) or non-olympus endoscopes (en-450bi5, ei-580bt or en-450p) were used in the procedures. In the procedures, a transparent hood was attached to the distal end of the endoscopes other than using jf-260v. In the subject procedures, pancreatitis in 9 patients, cholangitis in 1 patient and perforation in 1 patient occurred. All cases of pancreatitis were mild and the symptoms were improved promptly with conservative medical treatment. The perforation was fixed by an emergency surgery. There was no information on which model of the endoscope was used in each procedure. Therefore, olympus is submitting mdr according to the number of the type of accidental symptom (pancreatitis, cholangitis and perforation). This is 3rd of 3 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02588 |
| MDR Report Key | 8201828 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2018-12-27 |
| Date of Report | 2019-03-03 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2008-07-22 |
| Date Added to Maude | 2018-12-27 |
| 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 | UNKNOWN |
| Product Code | GCQ |
| Date Received | 2018-12-27 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-12-27 |