MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN; SMALL INTESTINAL VIDEOSCOPE

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp (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 could not be determined.

Event Description

On may 11, 2018, olympus medical systems corp.(omsc) received a literature titled ¿study on bile duct stone treatment using short-sbe (single balloon endoscope) for patients who experienced intestinal reconstructive surgery¿.The literature reported the result of the 104 procedures of stone treatments which were conducted between july 2013 and october 2017 at the user facility.In the 104 procedures, olympus small intestinal videoscopes ( sif-y0004, sif-y0015, sif-h290s ) were used.The literature reported following 14 case of accidental symptoms occurred in the procedures.Pancreatitis in 7 cases, cholangitis in 4 cases, perforation in 3 cases.Omsc reviewed the complaint record on the user facility and confirmed that olympus already submit 12 medical reports on the 12 of 14 accidental symptoms as follows; 8010047-2017-01619, 8010047-2017-01597, 8010047-2017-01594, 8010047-2017-01598, 8010047-2017-01599, 8010047-2017-01600, 8010047-2017-01601, 8010047-2017-01602, 8010047-2017-01603, 8010047-2017-01604, 8010047-2017-01605, 8010047-2017-01606.Since there was no information on the model of the small intestinal videoscopes that was used in the procedures, omsc is submitting mdrs according to the two additional accidental symptoms cases (pancreatitis in 1cases, perforation in 1 cases).This is one of two reports.

• Brand Name: UNKNOWN
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7581153
• MDR Text Key: 110449723
• Report Number: 8010047-2018-01095
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other