FDA.reportPublic FDA data

MAUDE MDR 5138640

MDR report key
5138640
Report number
1043572-2015-00097
Event key
0
Event type
3
Date of event
2015-09-08
Date received
2015-10-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KATHRYN CADORETTE
Address
5960 HEISLEY ROAD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HARMONY CONNECTPOINTCONNECTPOINTSTERIS CORPORATION - MONTGOMERYLMDY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-080

Event Narratives#

N

Patient 1

AT THE FACILITY'S REQUEST, A STERIS SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY TO INSPECT THE HARMONY CONNECTPOINT. THE TECHNICIAN INSPECTED THE UNIT AND SURGICAL LIGHTING SYSTEM AND FOUND THE EQUIPMENT WAS OPERATING ACCORDING TO SPECIFICATION. THERE WAS NO MALFUNCTION OF THE HARMONY CONNECTPOINT AND NO REPAIRS OR ADJUSTMENTS WERE REQUIRED. THE HARMONY CONNECTPOINT OPERATOR MANUAL SECTION 6.1 STATES, "POSITION THE HARMONY CONNECTPOINT TO MINIMIZE INTERFERENCE WITH OPERATING ROOM PERSONNEL DURING PROCEDURES." THE STERIS TECHNICIAN WAS INFORMED THAT THE DOCTOR PERFORMING THE PROCEDURE IN THIS EVENT WAS NOT FAMILIAR WITH THE HARMONY CONNECTPOINT AND WAS UNAWARE THAT THE DVI CORD SHOULD NOT HAVE BEEN DRAPED OVER THE LIGHT ARM DURING THE PROCEDURE. PERSONNEL FROM THE FACILITY INFORMED THE STERIS TECHNICIAN THAT IT IS THE HOSPITAL'S PROCEDURE TO RUN ALL CORDS, INCLUDING DVI CORDS, UNDER THE SURGICAL TABLE DURING PATIENT PROCEDURES TO AVOID INTERRUPTING THE STERILE FIELD. THE DOCTOR IN THIS EVENT HAS SINCE BEEN MADE AWARE OF THE IMPORTANCE OF POSITIONING THE HARMONY CONNECTPOINT AND CONNECTIONS SO AS TO MINIMIZE INTERFERENCE WITH THE OPERATING ROOM PERSONNEL DURING PROCEDURES. NO FURTHER ISSUES HAVE BEEN REPORTED.

D

Patient 1

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE DVI CORD, CONNECTED TO THE HARMONY CONNECTPOINT, WAS DRAPED OVER A SURGICAL LIGHT ARM TO SUPPORT IT AWAY FROM THE STERILE FIELD. DURING THE PROCEDURE, THE LIGHT ARM WAS REPOSITIONED AND THE DVI CORD FELL INTO THE STERILE FIELD. THERE WAS NO INJURY REPORTED. A PROCEDURAL DELAY WAS REPORTED.