FDA.reportPublic FDA data

MAUDE MDR 7559966

MDR report key
7559966
Report number
9610773-2018-00051
Event key
0
Event type
3
Date received
2018-06-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DANIEL WLADOW
Address
KUEHNSTRASSE 61 HAMBURG 22045 GM
Phone
494-494-4940
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WORKING INSERT, ALBARRAN, TWO WAYWORKING INSERTS WITH ALBARAN LEVEROLYMPUS WINTER & IBE GMBHGCPA20972AA20972A142WR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-010

Event Narratives#

N

Patient 1

THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

D

Patient 1

OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE AT AN UNKNOWN DATE, THE ALBARRAN LEVER AT THE DISTAL END OF THE WORKING INSERT BROKE OFF. IT IS UNKNOWN WHETHER A FRAGMENT FELL INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.