FDA.reportPublic FDA data

MAUDE MDR 6117114

MDR report key
6117114
Report number
3003974370-2016-00012
Event key
0
Event type
3
Date of event
2016-10-28
Date received
2016-11-21
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. ROLAND JEHLE
Address
MAX SCHMIDHEINY STRASSE 201 HEERBRUGG, ST. GALLEN 9435 SZ
Phone
717-717-7172
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEICA MDRS4SURGICAL MICROSCOPE ACCESSORYLEICA MICROSYSTEMS (SCHWEIZ) AGEPTMDRS4Y *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-210

Event Narratives#

N

Patient 1

AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING THE INVESTIGATION.

D

Patient 1

LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT ON (B)(6) 2016 FROM (B)(6) STATING THAT IN THE MIDDLE OF A TUMOR SURGERY, SMOKE CAME FROM THE SURGICAL MICROSCOPE CAUSED BY A BURNT RECORDING SYSTEM MDRS4 CABLE. THE SURGICAL MICROSCOPE POWERED OFF ON ITS OWN. THE SURGICAL MICROSCOPE COULD BE TURNED ON AFTER 5 TO 10 MINUTES BUT NOT THE RECORDING SYSTEM MDRS4. ITS HARD DISC POWER SUPPLY CABLE WAS BURNT. THERE WAS NO PATIENT/USER HARM. THE SURGERY WAS COMPLETED WITH THE SAME DEVICE.

N

Patient 1

THIS IS A FINAL REPORT. INITIAL INVESTIGATION (VISUAL INSPECTION) SHOWED THAT THE PART, WHICH CAUSED THE MALFUNCTION, IS A MEDICAL VIDEO RECORDER (LEICA MDRS4). THE UNIT WAS SENT TO THE SUPPLIER FOR DETAILED INVESTIGATION. ROOT CAUSE ANALYSIS REVEALED THAT THE MANUFACTURING PROCESS FOR THIS SATA POWER CABLE HAD A CLEANING PROCESS WHERE PHOSPHORIC ACID SOLUTION WAS USED AS A CLEANING AGENT ON THE GOLD CONTACTS. THE PHOSPHORIC ACID SOLUTION WICKS ALONG THE DIELECTRIC CHANNELS BY CAPILLARY ACTION, INTO THE CONNECTOR HOUSING, AND BECOMES ENTRAPPED IN THE REGION WHERE THE UNPROTECTED COPPER IS SUSCEPTIBLE TO CORROSIVE ATTACK. AN INADEQUATE RINSING PROCESS MAY HAVE OCCURRED, INCAPABLE OF REMOVING THE REMAINING TRAPPED SOLUTION. THROUGH THE TIME, CORROSION PRODUCES PARTICLE THAT ACTS AS BRIDGES, WHICH EVENTUALLY INDUCED THE ELECTRICAL SHORT-CIRCUIT RESULTING IN THE OVER-HEATING AND BURNING OF THE PLASTIC NON-FLAMMABLE INSULATION.