FDA.reportPublic FDA data

MAUDE MDR 8062205

MDR report key
8062205
Report number
2951238-2018-00700
Event key
0
Event type
3
Date received
2018-11-12
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
MS. CONNIE TUBERA
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SINGLE USE ASPIRATION NEEDLEVIZISHOT 2 FLEXGYRUS ACMI, INC.KTINA-U403SX-4019NA-U403SX-4019JF797397Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-120

Event Narratives#

N

Patient 1

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION DID NOT CONFIRM THE COMPLAINT FOR BROKEN OFF NEEDLE TIP BUT DID FIND DAMAGE TO THE DISTAL TIP OF THE SHEATH, AS WELL AS A KINK NEAR THE UPPER HYPOTUBE. THE NEEDLE WAS ALSO BENT AND SLIGHTLY UNFURLED. A POTENTIAL SCENARIO IS THAT THE DISTAL TIP OF THE NEEDLE CAUGHT ON THE SHEATH DURING ADVANCEMENT, CAUSING THE NEEDLE TO BEND AND SLIGHTLY UNFURL. THEN ON RETRACTION THE BENT NEEDLE CAUGHT THE HYPOTUBE AND PULLED IT PROXIMALLY, DISPLACING IT FROM EXPECTED POSITION. POTENTIAL CONTRIBUTORS ARE EXCESS FORCE AND OPERATOR'S TECHNIQUE. AS A PREVENTIVE MEASURE, THE NEEDLE INSTRUCTION MANUAL STATES, ?ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE IN CASE THE PRIMARY INSTRUMENT MALFUNCTIONS.? TO PREVENT BREAKAGE, THE NEEDLE INSTRUCTION MANUAL ALSO WARNS, ?DO NOT USE AN ASPIRATION NEEDLE THAT HAS AN IRREGULARLY BENT OR DEFORMED NEEDLE TUBE.? ?DO NOT APPLY BENDING FORCE TO THE HANDLE SECTION. DOING SO MAY DAMAGE THE INSTRUMENT AND/OR ENDOSCOPE.? ?DO NOT COIL THE INSERTION PORTION WITH A DIAMETER OF LESS THAN 150 MM. DOING SO COULD DAMAGE THE INSTRUMENT.? AND ?DO NOT TRY TO STRAIGHTEN A BENT OR DEFORMED NEEDLE WITH YOUR HANDS BECAUSE THE NEEDLE MAY BREAK.? THE INSTRUCTION MANUAL ALSO HAS DIRECTIONS FOR PRE-PROCEDURE VISUAL INSPECTION AND FUNCTIONAL VERIFICATION OF THE NEEDLE DEVICE.

D

Patient 1

1 OF 2. OLYMPUS WAS INFORMED THAT DURING AN EBUS-TBNA PROCEDURE, THE TIP OF THE NEEDLE BROKE AT THE FIRST PUNCTURE ATTEMPT AND FELL INTO THE PATIENT. THE BROKEN OFF TIP WAS RETRIEVED WITH ANOTHER UNKNOWN DEVICE. THERE WAS NO REPORTED ADDITIONAL BLEEDING OR PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE. BEFORE THE BREAKAGE, THERE WERE NO REPORTED PROBLEMS WITH NEEDLE INSERTION, NO NEEDLE BENDING, AND NO UNUSUAL PHENOMENA DURING THE PROCEDURE. THE EQUIPMENT HAD BEEN INSPECTED BEFORE USE, WITH NO ANOMALIES FOUND.