MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2018-11-28 for SWING TIP CANNULA UNKNOWN manufactured by Olympus Medical Systems Corp..
[128569046]
The subject device was not returned to olympus medical systems corp. (omsc). The exact cause has been under investigation. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10
[128569047]
Olympus received the following literature. Article title: "uncomplicated common bile duct stone removal guided by cholangioscopy versus conventional endoscopic retrograde cholangiopancreatography" summary: during an endoscopic retrograde cholangiopancreatography, which were performed between december 2015 and october 2016, the swing tip cannulas or the competitor's cannulas were used for 50 procedures. The mean age of the patients was 63 years. The ratio of male-to-female was 48:52. The following adverse events occurred. -mild post-ercp pancreatitis in 2 patients. -post-sphincterotomy bleeding in 4 patients. Duodenal perforation in 1 patient. New onset of cholangitis in 1 patient. There was no report of additional treatment in every cases. No further information was provided. This is the report regarding duodenal perforation in 1 patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02299 |
| MDR Report Key | 8109598 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-11-28 |
| Date of Report | 2018-12-20 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2018-11-28 |
| 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 | SWING TIP CANNULA |
| Generic Name | UNKNOWN |
| Product Code | ODD |
| Date Received | 2018-11-28 |
| Model Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-28 |