FDA.reportPublic FDA data

MAUDE MDR 7665996

MDR report key
7665996
Report number
3003974370-2018-00006
Event key
0
Event type
3
Date of event
2018-06-18
Date received
2018-07-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. ROLAND JEHLE
Address
MAX-SCHMIDHEINY-STRASSE 201 HEERBRUGG, SANKT GALLEN 9435 SZ
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEICA M820 F40SURGICAL MICROSCOPELEICA MICROSYSTEMS (SCHWEIZ) AGFSOY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-0601. R

Event Narratives#

N

Patient 1

THIS IS A COMBINED INITIAL AND FINAL REPORT. PATIENT INFORMATION HAS BEEN REQUESTED. HOWEVER, THE USER FACILITY DECLINED TO PROVIDE THIS INFORMATION TO THE MANUFACTURER DUE TO DATA PRIVACY LAWS IN EU. A SALES REPRESENTATIVE OF LEICA MICROSYSTEMS (B)(4) CHECKED THE CONFIGURATION OF THE DEVICE ON SITE AND TOOK PICTURES. THERE WAS NO DEVICE FAILURE VISIBLE. A TEST MADE AT LEICA MICROSYSTEMS (B)(4) BY SUBJECT MATTER EXPERTS ON A SAMPLE DEVICE SHOWED THAT WHEN FITTING THE STEREO ATTACHMENT TO THE BEAM SPLITTER THERE IS A CLICKING SOUND WHICH INDICATES THAT IT ENGAGED. ONCE THE KNURLED RING IS TIGHTENED THE STEREO ATTACHMENT CANNOT FALL. WE CONCLUDE THAT THE INCIDENT IS CAUSED BY A USER ERROR. THE USER FAILED TO FOLLOW THE INSTRUCTIONS GIVEN IN THE USER MANUAL (LEICA M844 - LEICA M820 / REF. 10 713 294 / VERSION 00) ON PAGE 18. THE SALES REPRESENTATIVE RE-TRAINED THE STAFF ON HOW TO ATTACH THE STEREO ATTACHMENT TO THE BEAM SPLITTER. FURTHERMORE HE SUGGESTED THE CUSTOMER TO PURCHASE A ROTATABLE BEAM SPLITTER IN ORDER TO AVOID THE ASSEMBLY AND DISASSEMBLY WHEN SWITCHING FROM ONE SIDE TO THE OTHER.

D

Patient 1

LEICA MICROSYSTEMS (B)(4) RECEIVED A COMPLAINT FROM FRANCE STATING THAT PRIOR TO SURGERY THE STEREO ATTACHMENT AND BINOCULAR TUBE FELL ONTO PATIENT'S FACE CAUSING A BROKEN NOSE AND A CUT BELOW THE EYE. THE SURGERY WAS NOT PERFORMED DUE TO SWELLING AND SHOCK.