FDA.reportPublic FDA data

MAUDE MDR 7016568

MDR report key
7016568
Report number
8010047-2017-01707
Event key
0
Event type
3
Date received
2017-11-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR KATSUAKI MORITA
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8 JA
Phone
426-426-4264
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPEFLEX 3D DEFLECTABLE VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWBLTF-190-10-3DR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-0901. O

Event Narratives#

N

Patient 1

THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP(OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WERE NOT PROVIDED FROM THE FACILITY. THERE WAS NO MALFUNCTION REPORT OF THE SUBJECT DEVICE CONCERNING THIS CASE. THE EXACT CAUSE COULD NOT BE DETERMINED.

D

Patient 1

ON OCTOBER 12, 2017, OLYMPUS MEDICAL SYSTEMS CORP (OMSC) RECEIVED A LITERATURE TITLED ?STUDY IN TREATMENT RESULTS AFTER LAPAROSCOPIC RECTAL RESECTION USING 3D ENDOSCOPE SYSTEM? THAT WAS MADE IN PUBLIC IN (B)(6) DIGESTIVE DISEASE WEEK IN (B)(6) 2017. THE LITERATURE REPORTED THE STUDY RESULT OF 24 CASES BETWEEN AUGUST 2014 AND DECEMBER 2016 COMPARED WITH THE RESULT BEFORE INTRODUCING THE OLYMPUS 3D ENDOSCOPE SYSTEM TO THE FACILITY. THE LITERATURE REPORTED THAT COMPLICATIONS AFTER THE SURGERY USING THE 3D ENDOSCOPE WERE WOUND INFECTION (ONE CASE), ANASTOMOTIC LEAKAGE (ONE CASE) AND PARALYTIC ILEUS (TWO CASES). COMPLICATIONS OF SURGERY USING NORMAL ENDOSCOPE WERE WOUND INFECTION (TWO CASES) AND ANASTOMOTIC (SIX CASES). IN CONCLUSION, THE LITERATURE STATED THAT THE RECTAL RESECTION USING THE 3D ENDOSCOPE SYSTEM POSSIBLY BRING IMPROVEMENTS IN ACCURACY IN THE PROCEDURE LESS INVASIVE RESULTS TO THE OPERATOR AND THE SYSTEM IS VERY USEFUL DEVICE ESPECIALLY FOR YOUNG SURGEONS. OMSC REVIEW THE SALES HISTORY RECORD FOR THE FACILITY AND CONFIRMED OLYMPUS LTF-S190-10 POSSIBLY USED IN THE PROCEDURES. THIS IS ONE OF FOUR REPORTS.