CANNULA PR-104Q-1

MAUDE Adverse Event Report

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..

Event Text Entries

[126655555] 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


[126655556] 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 pneumonia.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-02152
MDR Report Key8053618
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2018-11-08
Date of Report2018-11-27
Date Mfgr Received2018-11-13
Date Added to Maude2018-11-08
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 NameCANNULA
Generic NameCANNULA
Product CodeODD
Date Received2018-11-08
Model NumberPR-104Q-1
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 2018-11-08

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