FDA.reportPublic FDA data

MAUDE MDR 8093298

MDR report key
8093298
Report number
8010047-2018-02236
Event key
0
Event type
3
Date of event
2018-10-30
Date received
2018-11-20
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 KAZUTAKA MATSUMOTO
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
1FD-412LR (JA)SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGEFD-412LR86KY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-200

Event Narratives#

N

Patient 1

THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE SUBJECT DEVICE WORKED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE EVENT OCCURRED DUE TO ANY OF THE FOLLOWING POSSIBLE CAUSES. THE CONTACT CONDITION BETWEEN THE PATIENT AND THE PATIENT PLATE WAS BAD. THE SUBJECT DEVICE WAS NOT CONNECTED TO THE CORD OR THE CORD WAS NOT CONNECTED TO THE POWER SUPPLY CORRECTLY. THE CURRENT DENSITY DECREASED DUE TO BURNT TISSUE ATTACHED TO THE DISTAL END. THE TARGET AREA WAS IMMERSED IN BLOOD. THE TARGET AREA WAS IMMERSED IN WATER. THE INSTRUCTION MANUAL OF THE DEVICE HAS DESCRIBED THE METHOD OF CONNECTION OF A CODE. THE INSTRUCTION MANUAL OF THE DEVICE HAS ALREADY WARNED AS FOLLOWS; PULLING THE TISSUE WHEN APPLYING THE CURRENT.

D

Patient 1

DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION, THE MALFUNCTION OF THE TWO DEVICES WAS REPORTED. IN THE PROCEDURE, THE DOCTOR USED TWO DEVICES FOR HEMOSTASIS, BUT THEY COULD NOT STOP BLEEDING. THE INTENDED PROCEDURE WAS COMPLETED WITH THIRD DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FAILURE OF STOPPING BLEEDING. THIS IS THE SECOND ONE OF TWO REPORTS.