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 2017-10-31 for UNKNOWN manufactured by Unknown.
[90844384]
The malfunction of the subject device concerning this case has not been reported. Also, since the serial number of this device is unknown, olympus medical systems corp. (omsc) could not confirm the manufacturing history. Because the user facility recognized as accidental symptom in the conclusion of the report, this case is not the malfunction of device, it seems to be accidental symptom. But the exact cause of the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[90844385]
The following article was reported at the 25th japan digestive disease week(jddw 2017). Article title: the study of endoscopic bile duct calculus treatment using short-sbe for postoperative reconstructed intestinal tract cases. Report summary: the article stated that studied the clinical usefulness of endoscopic bile duct calculus treatment using short single balloon endoscope (short-sbe) for postoperative reconstructed intestinal tract cases. The target of this report are procedures of endoscopic retrograde cholangiopancreatography(ercp)-related procedures using short-sbe (products: (b)(4) from (b)(6) 2013 to (b)(6) 2017, and calculus treatment procedures using duodenoscope(jf group) during the same period. In the subject procedures, accidental symptoms occurred as follows. Short-sbe group: pancreatitis 6 cases, cholangitis 4 cases, perforation 2 cases. Jf group: accidental symptoms (details are unknown) 12 cases. Conclusion: accidental symptoms of treatment of bile duct calculus using short-sbe in the postoperative reconstructed intestinal tract was within acceptable range, and it was able to carry out safely in the same way as usual treatment of bile duct calculus using duodenoscope. This is 9 of 24 reports. Short-sbe group: cholangitis 3 of 4 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01603 |
| MDR Report Key | 6989711 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2017-10-31 |
| Date of Report | 2017-11-01 |
| Date Mfgr Received | 2017-10-12 |
| Date Added to Maude | 2017-10-31 |
| 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 | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | FDP |
| Date Received | 2017-10-31 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-10-31 |