SWING TIP CANNULA UNKNOWN

MAUDE Adverse Event Report

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..

Event Text Entries

[128562087] 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


[128562088] Olympus received the following literature. Article title: "uncomplicated common bile duct stone removal guided by cholangioscopy versus conventional endoscopic retrograde cholangiopancreatography". 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 mild post-ercp pancreatitis in 2 patients.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-02297
MDR Report Key8109595
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2018-11-28
Date of Report2018-12-20
Date Mfgr Received2018-12-10
Date Added to Maude2018-11-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR KAZUTAKA MATSUMOTO
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO 192-8507
Manufacturer CountryJA
Manufacturer Postal192-8507
Manufacturer Phone426425177
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWING TIP CANNULA
Generic NameUNKNOWN
Product CodeODD
Date Received2018-11-28
Model NumberUNKNOWN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.