MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number LTF-190-10-3D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined because the subject device was not returned omsc for evaluation.

Event Description

On (b)(6) 2020, olympus medical systems corp.(omsc) became aware of a news article regarding three urgent re-operations in a week due to complications after endoscopic surgeries.According to the article, in december 2016, three patients developed peritonitis after endoscopic surgery to remove digestive cancer.And urgent re-operations were performed for the patients in a week.The three endoscopic surgeries were performed by the same physician.In addition to the peritonitis, the following incidents were also observed.- nutrient leakage into the abdominal cavity due to a tube coming off the intestine.- intestinal damage likely due to contact with certain surgical equipment.- necrosis of the colon due to amputation of an artery that should have been preserved.There is no information available indicating a direct relationship between the reported adverse events and olympus products on (b)(6) 2020, olympus followed up with the user facility and was informed that olympus endoeye flex 3d deflectable videoscope (ltf-190-10-3d) and other two olympus products were used in endoscopic surgeries.According to the number of the patients and the number of olympus devices which might have contributed to the peritonitis, omsc is submitting three medical device reports.This is two of three reports.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX 3D DEFLECTABLE 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: 9936655
• MDR Text Key: 189763198
• Report Number: 8010047-2020-02044
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LTF-190-10-3D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2014
• 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