MAUDE MDR 8385831

MDR report key
8385831
Report number
8385831
Event key
0
Event type
3
Date of event
2018-12-12
Date received
2019-03-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UROSKOP OMNIASYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIEDSIEMENS AG/SIEMENS HEALTHCARE GMBHJAAUROSKOP OMNIA* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-040

Event Narratives#

D

Patient 1

EVERYTHING WAS READY TO GO IN THE ROOM FOR SURGERY AND PT HAD ALREADY BEEN PUT TO SLEEP BUT WHEN THE SURGERY STARTED THE SURGEON WAS NOT ABLE TO TAKE X-RAY, MULTIPLE ATTEMPTS TO FIX THE PROBLEM BUT STILL UNABLE TO, SO NEW BED AND X-RAY MACHINE HAD TO BE BROUGHT TO THE ROOM. ROUTINE BED MAINTENANCE COMPLETED ON TABLE IN OR ONE DAY PRIOR TO INCIDENT. THIS CASE WAS THE FIRST CASE PERFORMED AFTER THE BED MAINTENANCE. ROUTINE PROCEDURE WAS TO BE PERFORMED AND PATIENT POSITIONED AS USUAL. WHEN SURGEON WAS TRYING TO GET X-RAY IMAGE NECESSARY TO PROCEED, IMAGE WAS VERY UNCLEAR AND THEN WENT BLACK. NUMEROUS ATTEMPTS WERE MADE TO GET IMAGE BY THE SURGEON WITHOUT SUCCESS AND WITH THE SAME RESULT. MAINTENANCE WAS IMMEDIATELY INFORMED AND BROUGHT TO THE OR. UNABLE TO DIAGNOSE THE PROBLEM DECISION WAS MADE TO TRANSFER THE PATIENT TO ANOTHER OR TABLE IN THE SAME ROOM AND BRING IN A PORTABLE C-ARM. THIS INVOLVED BREAKING DOWN THE STERILE FIELD, REPOSITIONING AND UTILIZATION OF AN INCREASED AMOUNT OF DISPOSABLE GOODS FOR THE CASE. THE PATIENT WAS UNDER ANESTHESIA FOR AN INCREASED AMOUNT OF TIME (APPROXIMATELY 45-60 MINUTES). I HAVE REQUESTED A DETAILED REPORT FROM THE COMPANY WHO FIXED THE BED AND HAVE NOT YET RECEIVED IT.