TYDINGS TONSIL SNARE, 7 3/8", 12 SNARE WIRES, 25 G *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-25 for TYDINGS TONSIL SNARE, 7 3/8", 12 SNARE WIRES, 25 G * manufactured by *.

Event Text Entries

[995621] The user facility reports that the tonsil snare failed to cut through tissue and release, necessitating the surgeon to remove add'l tissue to free the snare and tonsil tissue. The snare push rod that is attached to the movable handle jumped out of the channel and jammed, preventing the snare contraction around tonsil. The surgery tech had to remove the thumbscrew to reset the snare. It appears that the distal channel is bent. The physician is concerned about where the snare was positioned, too close to carotid artery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	2430952-2008-00023
MDR Report Key	1230100
Date Received	2008-07-25
Date of Report	2008-07-07
Date of Event	2008-06-17
Date Facility Aware	2008-06-17
Report Date	2008-07-07
Date Added to Maude	2008-11-17
Event Key	0
Report Source Code	Distributor report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	TYDINGS TONSIL SNARE, 7 3/8", 12 SNARE WIRES, 25 G
Generic Name	JARIT THROAT/LARYNGEAL
Product Code	KBZ
Date Received	2008-07-25
Returned To Mfg	2008-06-20
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	1281181
Manufacturer	*
Manufacturer Address	* * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-07-25