MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN; DUODENOVIDEOSCOPE

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to omsc.Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿patient-related factors associated with successful cannulation by trainees during hands-on endoscopic retrograde cholangiopancreatography training¿.The literature reported the result from two multicenter studies that 1044 patients who aged 18-90 years with native papilla underwent ercp using olympus duodenoscope between december 2013 and october 2017.There was no detailed information on which model of the endoscope was used in each procedure.The literature only provided ¿duodenoscope¿.In the subject procedures, 46 cases of post-ercp pancreatitis, 18 cases of bleeding, 16 cases of biliary infection, and 6 cases of unspecified complications reportedly occurred.Based on the available information, a direct relationship between the subject devices and the reported adverse events could not be determined.Omsc is submitting 4 mdrs according to the number of the adverse event types (for post-ercp pancreatitis, bleeding, biliary infection, and unspecified complication).This report is 4 of 4.(related to unspecified complication).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus followed up with the literature authors to obtain additional information.However, the authors did not report anything.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.This report is 4 of 4.

• Brand Name: UNKNOWN
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9294379
• MDR Text Key: 184939018
• Report Number: 8010047-2019-03897
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,user facil
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other