FDA.reportPublic FDA data

MAUDE MDR 2397229

MDR report key
2397229
Report number
1518293-2011-00231
Event key
0
Event type
3
Date of event
2011-11-10
Date received
2011-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
DAVID BENSON
Address
2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US
Phone
513-513-5139
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HUT EXT DR FINAL ASSY-STANDARDUROLOGY SUITELIEBEL-FLARSHEIM CO.KQSHUT EXT DR404008NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-290

Event Narratives#

D

Patient 1

ON (B)(6) 2011: CUSTOMER REPORTS VIA PHONE THAT DURING AN UNK UROLOGY PROCEDURE, HANDSWITCH AND FOOTSWITCH WERE NOT FUNCTIONING, WHICH DISALLOWED TABLE MOVEMENT. STAFF WAS ABLE TO MOVE THE PT MANUALLY AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. NO INJURY TO REPORT.

N

Patient 1

FIELD SERVICE ENGINEER (FSE) TROUBLESHOT REPORTED TABLE MOVEMENT COMPLAINT AND FOUND THE HAND CONTROL HAD FAILED. FSE REPLACED THE HAND CONTROL ASSEMBLY ACCORDANCE WITH SYSTEM INSTALL AND SERVICE MANUAL AND THE TABLE MOVEMENT RETURNED TO NORMAL. SYSTEM WAS TESTED ACCORDING TO THE SERVICE MANUAL AND RETURNED TO FULL SERVICE BY THE CUSTOMER.