FDA.reportPublic FDA data

MAUDE MDR 835056

MDR report key
835056
Report number
1519132-2007-00002
Event key
0
Event type
3
Date received
2007-02-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
TERRENCE SULLIVAN
Address
136 TURNPIKE RD SOUTHBOROUGH MA 01772 US
Phone
508-508-5088
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BLADE EXTENDER KIT500ACMI NORWALKEQNLAR-AELAR-AEAG8325NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-02-120

Event Narratives#

D

Patient 1

EXTENDER BLADE WAS LOST DOWN THE PATIENT'S THROAT DURING INTUBATION. THE BLADE WAS PROPERLY ATTACHED, BUT SLIPPED OFF. THE NURSE NOTICED THAT THE BLADE WAS MISSING, THEY SEARCHED THE ROOM FOR THE BLADE BUT COULD NOT FIND IT. THE DOCTOR TRIED TO RESCOPE THE PATIENT'S ESOPHAGUS AND COULDN'T SEE ANYTHING. THEN THEY BROUGHT IN A FLOURO MACHINE AND STILL COULDN'T SEE ANYTHING BECAUSE THE ITEM IS NOT RADIOPAQUE. THEY USED A LONG FLEXIBLE SCOPE DOWN THE PATIENT'S THROAT AND SAW THE EXTENDER BLADE 6" - 8" DOWN THE THROAT. THEY RETRIEVED IT WITH A GRASPER AND REMOVED IT.

N

Patient 1

DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR ANALYSIS. AT THIS TIME NO CONCLUSIONS CAN BE DRAWN REGARDING THE REPORTED EVENT. SHOULD THE DEVICE BE MADE AVAILABLE FOR EVALUATION, GYRUS ACMI WILL PROVIDE AN UPDATED REPORT TO THE AGENCY.