MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-12-17 for CANNULA PR-110Q-1 manufactured by Olympus Medical Systems Corp..
[130618390]
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. The malfunction of the subject device was not reported. The subject device is done the 100% inspection. The author has not provided additional information about individual cases. Therefore, the exact cause of the reported event could not be conclusively determined. Omsc assumes that the cause of this event is not related to the malfunction of the device. It was known that the endo-therapy devices using for the biliary or pancreatic tree could lead to a pancreatitis. The instruction manual of the device has already noted as follows; limited studies indicate that: acute pancreatitides are caused most frequently as cases of post- diagnostic ercp, and that 50% of the causes of deaths are made up of pancreatitis? Becoming severe; this is followed by perforation, and most of the site of perforation are descending limb. Limited studies indicate that acute pancreatitides following ercp are mostly mild cases; however, once in a while, severe cases exist, in which failure of multiple organs and disseminated intravascular coagulation are developed successively leading to death.
Patient Sequence No: 1, Text Type: N, H10
[130618391]
In the paper "efficacy and safety of pancreatic juice cytology by using synthetic secretin in the diagnosis of pancreatic ductal adenocarcinoma", published in the journal "digestive endoscopy 2018; 30: 771-776", the following were reported; 138 cases of pancreatic juice cytology (pjc) were done to detect the pancreatic ductal adenocarcinoma (pdac). The subject product or (b)(4) (boston scientific) was used for pjc. 12 patients suffered mild pancreatitis as a complication. All 12 patients were immediately cured with conservative medical treatment. It was unknown whether the subject product was used in the mild pancreatitis-occurred cases. The malfunction of the subject product was not reported. This is the report regarding the occurring of the pancreatitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02445 |
| MDR Report Key | 8171833 |
| Report Source | LITERATURE |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-18 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-12-17 |
| 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 | 2018-12-17 |
| Model Number | PR-110Q-1 |
| 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 | 2018-12-17 |