FDA.reportPublic FDA data

MAUDE MDR 2058926

MDR report key
2058926
Report number
3002985827-2011-00001
Event key
0
Event type
3
Date of event
2011-02-11
Date received
2011-04-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ANGIE KILGORE
Address
4481 CAMPUS DR KALAMAZOO MI 49008 US
Phone
269-269-2695
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MICROMMICROTOMEMICROM INTERNATIONAL GMBHIDLHM355S-3905200Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-0101. R

Event Narratives#

D

Patient 1

ON (B)(6) 2011, A TECHNICIAN WAS ROUTINELY CUTTING BLOCKS. THE TECH PRESSED THE STOP BUTTON ON THE CONSOLE AND THE CHUCK CAME TO THE TOP AND PAUSED. AS IT PAUSED, THE TECH GRASPED THE BLOCK TO REMOVE IT FROM THE CHUCK AND THE CHUCK THEN ALLEGEDLY BEGAN TO MOVE. THIS RESULTED IN INJURY TO THE TECH IN THE FORM OF A LACERATION TO THE INDEX FINGER AND THUMB. THE TECH WAS TREATED AND INTERVENTION WAS REQUIRED TO PREVENT PERMANENT DAMAGE. COMPANY WAS NOTIFIED ON (B)(6) 2011. TWO SAFETY FEATURES EXIST TO PREVENT THIS TYPE OF INJURY AS DETAILED IN THE INSTRUCTIONS FOR USE. THESE FEATURES INCLUDE A MANUAL BRAKE WHICH PREVENTS THE WHEEL AND CHUCK FROM MOVING AND A PHYSICAL GUARD THAT IS PLACED OVER THE KNIFE DURING BLOCK CHANGES. NEITHER SAFETY FEATURE WAS EMPLOYED BY THE USER IN THIS CASE.