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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE Back to Search Results
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 (b)(6) 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 three of three reports.

 
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Brand NameENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
Type of DeviceFLEX 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 Key9936682
MDR Text Key190946049
Report Number8010047-2020-02045
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK123365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
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 Received04/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLTF-190-10-3D
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/17/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/08/2020 Patient Sequence Number: 1
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