FDA.reportPublic FDA data

MAUDE MDR 8563064

MDR report key
8563064
Report number
2083544-2019-00001
Event key
0
Event type
3
Date of event
2019-04-05
Date received
2019-04-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. SOLMAZ SHAIDA
Address
1750 WEST 214TH STREET TORRANCE 90501 US
Phone
310-310-3109
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOMEAUTOSECTIONSAKURA FINETEK USA, INC.IDO5000R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-2901. O

Event Narratives#

N

Patient 1

SAKURA INVESTIGATION IDENTIFIED THAT THE CAUSE AS USER ERROR. CUSTOMER STATED THAT THE USER STARTED A TRIM THEN DECIDED SHE DIDN'T WANT IT, PRESSED THE TRIM BUTTON MULTIPLE TIMES TO STOP IT. HOWEVER, PRESSING THE TRIM BUTTON AGAIN AFTER A TRIM HAS BEEN STARTED WILL NOT IMMEDIATELY STOP THE CURRENT OPERATION, IT WILL STOP IT AT THE END OF THE CURRENT TRIM CYCLE. EXAMINATION OF THE LOG FILE SHOWS THAT THE TRIM BUTTON WAS PRESSED SIX TIMES BEFORE THE EMERGENCY STOP BUTTON WAS PRESSED. CUSTOMER STATED THAT THE TRIM BUTTON WAS PRESSED TO STOP THE MOVEMENT OF THE BLADE. BASED ON THE INVESTIGATION AND CUSTOMER FEEDBACK, IT WAS CONCLUDED THAT THE USER WAS TRIMMING THE TISSUE BLOCKS ROUTINELY, REPLACED THE TRIMMED TISSUE BLOCKS WITH NEW SAMPLES AND CUT HER THUMB AS SHE REACHED FOR THE BLOCK WHILE THE AUTOSECTION WAS STILL MOVING. TO IMMEDIATELY STOP THE OPERATION, THE EMERGENCY STOP BUTTON SHOULD HAVE BEEN PRESSED. FROM THIS EXAMINATION IT WAS DETERMINED THAT THE CAUSE OF THE INCIDENT WAS OPERATOR ERROR, PRESSING A WRONG BUTTON IN ATTEMPT TO STOP THE INSTRUMENT. A MAINTENANCE CHECK WAS PERFORMED ON APRIL 8TH AND 9TH, 2019 OF THE SUBJECT INSTRUMENT. NO INDICATION OF MALFUNCTION WAS IDENTIFIED. CUSTOMER WAS STILL USING THE INSTRUMENT IN THEIR DAILY ROUTINE WORK AT THAT TIME; HOWEVER, THE INSTRUMENT WAS TAKEN OUT OF COMMISSION FOLLOWING AN INTERNAL SAFETY REVIEW ON APRIL 11, 2019. MICROTOME BLADES ARE EXTREMELY SHARP AND INHERENTLY DANGEROUS. INATTENTION TO THE TASK AT HAND AND FAILURE TO UTILIZE SAFETY DEVICES CAN CAUSE A SERIOUS INJURY. THE AUTOSECTION INSTRUMENT IS EQUIPPED WITH A RED COLORED BLADE GUARD AND AUDIO/VISUAL ALERT AS A SAFETY DEVICE TO PROTECT THE USER FROM ACCIDENTAL EXPOSURE TO THE BLADE EDGE AND INJURY WHEN USED PROPERLY. THE OPERATING MANUAL OF THE AUTOSECTION, SEC 1.4.1 WARNINGS AND 4.6 ROUTINE OPERATION - WARNINGS, CLEARLY STATES THAT USER MUST "ALWAYS LOCK THE HAND WHEEL AND COVER THE CUTTING EDGE WITH THE BLADE GUARD PRIOR TO MANIPULATING THE BLADE OR THE SPECIMEN, CHANGING THE SPECIMEN, OR WHEN THE INSTRUMENT IS NOT IN USE." THE INSTRUMENT DID NOT MALFUNCTION OR CAUSE THIS INJURY; IT FUNCTIONED AS INTENDED ACCORDING TO THE SPECIFICATIONS AND IS SAFE TO USE. (B)(4).

D

Patient 1

SAKURA WAS INFORMED ABOUT A USER CUT INJURY ON (B)(6) 2018, IN (B)(6), WITH THE AUTOSECTION, SER# (B)(4). USER ACCIDENTALLY CUT ABOUT 10 MM OF TIP OF THE THUMB AND REQUIRED PLASTIC SURGERY TO REATTACH IT.