FDA.reportPublic FDA data

MAUDE MDR 952063

MDR report key
952063
Report number
1225968-2007-00001
Event key
0
Event type
3
Date of event
2007-10-19
Date received
2007-11-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
DENIIS DEVONA
Address
3 CATALPA RD. PROVIDENCE RI 02906 US
Phone
401-401-4014
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VOCAL FOLD INFUSION NEEDLELARYNGEAL INJECTING DEVICEENDOCRAFT LLC.KAAUMG 100AUMG 100A110205NNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-11-2101. R

Event Narratives#

D

Patient 1

THE OPERATING NURSE CONTACTED US AND INDICATED THAT DR HAD BROKEN A VOCAL FOLD INFUSION NEEDLES FROM ITS SHAFT WHILE USING IT TO INJECT THE ESOPHAGUS OF A PT.

N

Patient 1

THE 'VOCAL FOLD INFUSION NEEDLE' WAS DESIGNED TO BE USED SOLELY FOR THE VOCAL FOLD THROUGH A DIRECT LARYNGOSCOPE AND WITH MAGNIFICATION PROVIDED BY A SURGICAL MICROSCOPE. FOR A NUMBER OF REASONS, IT IS NOT SAFE TO USE AN ANGLED LARYNGEAL NEEDLE IN OTHER SITES SUCH AS THE ESOPHAGUS, WHICH IS EXACTLY WHAT WAS DONE IN THIS CASE. AS YOU WILL NOTE IN THE DIAGRAMS IN THE INSTRUCTIONS-FOR-USE THAT ACCOMPANIED THE NEEDLES, ONLY THE DISTAL ANGLED 3MM TIP OF THE NEEDLE SHOULD HAVE BEEN PENETRATING THE TISSUE SO THAT ANY FORCE-RELATED BENDING SHOULD HAVE BEEN OBVIOUS WHILE VIEWING THROUGH THE SURGICAL MICROSCOPE. THEREFORE, THE SURGEON SHOULD HAVE SEEN THE NEEDLE IF IT WAS BENDING OR BREAKING. FURTHERMORE, EVEN IF THE EXCESSIVE FORCE-RELATED BENDING WAS MISSED AND THE NEEDLE FRACTURED FROM THE SHAFT, IT SHOULD HAVE BEEN SIMPLE TO REMOVE THE NEEDLE. SINCE ONLY THE DISTAL ANGLED ASPECT OF THE NEEDLE SHOULD HAVE BEEN IN THE SOFT TISSUE, THE PROXIMAL ASPECT OF THE NEEDLE WOULD HAVE BEEN EASILY SEEN EMANATING FROM THE SURGEON'S PUNCTURE SITE. THE OPERATING NURSE EXPLAINED THAT SHE WAS SURPRISED AT THEIR CURRENT SCENARIO EXPLAINING THAT NO ONE AT THEIR INSTITUTION HAD PRIOR DIFFICULTIES WITH THE VOCAL FOLD INFUSION NEEDLES. IN FACT, THIS IS THE FIRST INDICATION OF A PROBLEM THAT ENDOCRAFT HAS HEARD ABOUT.