MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-11-08 for CANNULA PR-104Q-1 manufactured by Olympus Medical Systems Corp..
[126654579]
The subject device was not returned to olympus medical systems corp. (omsc). Omsc could not obtain additional information about individual cases. 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
[126654580]
The following events were reported in the endoscopy 2018; 50: 33? 39: article title: "transpancreatic precut papillotomy versus double-guidewire technique in difficult biliary cannulation: prospective randomized study. " summary: during the biliary cannulation which were performed between april 2011 and march 2014, pr-104q were used. The biliary cannulation were performed with transpancreatic precut papillotomy and double guidewire technique as follows; 1) the biliary cannulation were performed with transpancreatic precut papillotomy. The total number of patients were 34 (male-to-female ratio was 18:16). The mean age of the patients was 69. 8 years. In this prospective study, it was reported as follows; mild pancreatitis developed in one patient. Cholangitis developed in one patient. The incidence of post-ercp hyperamylasemia was 20. 6% (7/34). There was no report of additional surgical treatment in all cases. 2) the biliary cannulation were performed with double guidewire technique. The total number of patients were 34 (male-to-female ratio was 19:15). The mean age of the patients was 67. 3 years. In this prospective study, it was reported as follows; severe pancreatitis developed in one patient. Pneumonia developed in one patient. The incidence of post-ercp hyperamylasemia was 20. 6% (7/34). There was no report of additional surgical treatment in all cases. This is the report regarding cholangitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02150 |
| MDR Report Key | 8053620 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-27 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-11-08 |
| 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 | CANNULA |
| Generic Name | CANNULA |
| Product Code | ODD |
| Date Received | 2018-11-08 |
| Model Number | PR-104Q-1 |
| 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 | 2018-11-08 |