FDA.reportPublic FDA data

MAUDE MDR 6613533

MDR report key
6613533
Report number
8010047-2017-00682
Event key
0
Event type
3
Date of event
2017-05-17
Date received
2017-06-05
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
1SINGLE USE INJECTORINJECTOR AND SHEATHSETOLYMPUS MEDICAL SYSTEMS CORP.FBKNM-401L-06236XKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-0501. O

Event Narratives#

N

Patient 1

THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEM CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD FOR THE LOT INDICATED NO ABNORMALITY WITH THE EVENT-RELATED ITEMS BELOW. INJECTION OF THE LIQUID. NEEDLE EXTENSION/RETRACTION. NO BENT, KINK, CRACK AND SCRATCH ON THE TUBE. BASED ON THE SIMILAR CASES IN THE PAST, IT WAS LIKELY THAT PHENOMENON OCCURRED DUE TO THE COMPRESSIVE BUCKLING ON THE NEEDLE TUBE. THE COMPRESSIVE BUCKLING ON THE NEEDLE TUBE WAS LIKELY CAUSED WHEN THE NEEDLE WAS EXTENDED BECAUSE OF THE LARGE FRICTION BETWEEN THE OUTER TUBE AND THE NEEDLE. IT WAS LIKELY THAT THE FRICTION BETWEEN THE OUTER TUBE AND THE NEEDLE INCREASED BY THE FOLLOWING FACTORS. THE NEEDLE WAS EXTENDED/RETRACTED WHILE THE TUBE WAS BENT AT INSPECTION OF OPERATION. THE SLIDER WAS ABRUPTLY PUSHED. THE BUCKLING OF THE TUBE. THE INSTRUCTION MANUAL OF THE DEVICE HAS ALREADY WARNED AS FOLLOWS; STRAIGHTEN OUT THE INSTRUMENT BEFORE INSPECTING IT. THE INSTRUMENT CAN BE DAMAGED IF IT IS COILED WHILE THE HANDLE IS OPERATED. OPERATE THE SLIDER SLOWLY, OTHERWISE THE TUBE COULD BUCKLE. WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, RETRACT THE NEEDLE INTO THE SHEATH, HOLD THE INSTRUMENT CLOSE TO THE BIOPSY VALVE, AND KEEP IT AS STRAIGHT AS POSSIBLE RELATIVE TO THE BIOPSY VALVE. OTHERWISE, THE INSTRUMENT COULD BE DAMAGED. INSERT THE INSTRUMENT SLOWLY. ABRUPT INSERTION COULD DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. STOP USING THE INSTRUMENT IF THE INSERTION PORTION BENDS EXCESSIVELY DURING USE. THIS COULD RESULT IN MALFUNCTION, SUCH AS FAILING TO EXTEND THE NEEDLE OR INJECT A FLUID.

D

Patient 1

DURING A PAEDIATRIC SCLEROTHERAPY, THREE DEVICES WERE USED. BEFORE USING THE FIRST DEVICE, NOTHING ABNORMAL WAS FOUND IN THE FIRST DEVICE OUTSIDE THE ENDOSCOPE. HOWEVER THE USER COULD NOT FLUSH WHEN HE OR SHE TRIED TO INJECT IN THE VARIX, AND THE FIRST DEVICE WAS RETRIEVED. THE USER COULD NOT STOP BLEEDING BECAUSE THE ETHANOLAMINE WAS NOT INJECTED INTO THE PATIENT. BLOOD PRODUCT WAS ADMINISTERED BY THE ANESTHESIOLOGIST AND THE SURGEON BECAUSE THE PATIENT CONDITION DETERIORATED. AS A RESULT, THE PROCEDURE TIME WAS PROLONGED. THE USER CONTINUED THE PROCEDURE WITH THE SECOND DEVICE, BUT THE USER COULD NOT FLUSH LIKE THE FIRST DEVICE. THE PROCEDURE WAS COMPLETED WITH THE THIRD DEVICE OF THE SAME MODEL. IT WAS REPORTED THAT PATIENT CONDITION WAS STABLE. THIS REPORT DESCRIBES THE FIRST DEVICE.