FDA.reportPublic FDA data

MAUDE MDR 7369009

MDR report key
7369009
Report number
9610773-2018-00027
Event key
0
Event type
3
Date of event
2018-03-01
Date received
2018-03-26
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 US
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 GMBHGCPA20972AA20972A051WR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-260

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 INSPECTION PRIOR TO AN UNSPECIFIED CYSTOSCOPY PROCEDURE, IT WAS NOTICED THAT THE ALBARRAN LEVER AT THE DISTAL END OF THE WORKING INSERT COULD NOT BE RAISED AND THAT ITS FIXING PIN WAS MISSING. IT IS UNKNOWN WHEN THIS DAMAGE OCCURRED AND WHETHER THE FIXING PIN POSSIBLY FELL OFF INSIDE THE PATIENT DURING A PREVIOUS PROCEDURE. SINCE THIS DAMAGE WAS DETECTED PRIOR TO USE, THE INTENDED CYSTOSCOPY PROCEDURE WAS CANCELED. THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.