FDA.reportPublic FDA data

MAUDE MDR 5986621

MDR report key
5986621
Report number
5986621
Event key
0
Event type
3
Date of event
2016-09-08
Date received
2016-09-29
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
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
1FLEX RETRATORRETRACTOR, ENT - FLEX RETRACTORMEDROBOTICS CORPORATIONKALR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-2901. O

Event Narratives#

N

Patient 1

D

Patient 1

PATIENT HERE FOR ROBOTIC ASSISTED SURGICAL REPAIR OF EPIGLOTTOPLASTY. POSITIONED PATIENT'S MOUTH OPEN FOR PROCEDURE WITH MEDROBOTICS FLEX RETRACTOR BY SURGEONS. AT END OF PROCEDURE WHEN RETRACTOR WAS REMOVED A SMALL OPEN AREA ON CHIN WAS DISCOVERED WHERE RETRACTOR HAD BEEN AGAINST. CLOSED WITH SUTURE BY SURGEONS AND BACITRACIN OINTMENT APPLIED. PICU RN NOTIFIED. MANUFACTURER RESPONSE FOR FLEX RETRACTOR, MEDROBOTICS FLEX RETRACTOR (PER SITE REPORTER): THE MEDROBOTICS REPRESENTATIVE IS AWARE OF THE SURGEON HAVING THE DEVICE AT PRESENT. THE REPRESENTATIVE'S NAME CAN BE MADE KNOWN TO THE COMPANY AS NEEDED (NOT AVAILABLE WHEN THIS MEDSUN WAS FILED). THE DEVICE WAS TAKEN BY THE REP AND USED AT ANOTHER FACILITY OUTSIDE OF OUR PARENT COMPANY IN MASSACHUSETTS. THE COMPANY HAS POSSESSION OF THE EQUIPMENT.