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 Perforation (2001)

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 two of two reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.On june 1st, 2019, 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¿ that was made in public in the 97th congress of the (b)(4) gastroenterological endoscopy society.The literature reported the result of the 128 procedures of stone treatments which were conducted between july 2013 and october 2018 at the user facility.In the 128 procedures, olympus small intestinal videoscopes (sif-y0004, sif-y0015, sif-h290s) were used.The literature reported following 13 cases of accidental symptoms occurred in the procedures.Pancreatitis in 7 cases.Cholangitis in 4 cases.Perforation in 2 cases (in both cases, the membrana mucosa was torn with the endoscope.The torn area was clipped with the clip and treated conservatively.) omsc reviewed the complaint record on the user facility and confirmed that omsc received another literature for the same study titled ¿study on bile duct stone treatment using short-sbe (single balloon endoscope) for patients who experienced intestinal reconstructive surgery¿ that was made in public in the 95th congress of the (b)(4) gastroenterological endoscopy society.The literature received in 2018 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 cases of accidental symptoms occurred in the procedures.Pancreatitis in 7 cases.Cholangitis in 4 cases.Perforation in 3 cases.Olympus already submit 14 medical device reports on the 14 accidental symptoms based on the literature received in 2018 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, 8010047-2018-01095, 8010047-2018-01096 the reason why the total number of accidental symptoms reported in the newer literature reduced is unknown.

• Brand Name: UNKNOWN
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7581056
• MDR Text Key: 110450299
• Report Number: 8010047-2018-01096
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other